llyn· · welc~l\llyn· sap dir: 80020273 version: c page 1 oflo manufacturer's declaration of...

$: llyn· · welc~l\llyn· sap dir: 80020273 version: c page 1 oflo manufacturer's declaration of conformity australian therapeutic goods (medical devices) regulations 2002$
Welc~l\llyn· SAP DIR: 80020273 Version: C Page 1 oflO

MANUFACTURER'S DECLARATION OF CONFORMITY

AUSTRALIAN THERAPEUTIC GOODS (MEDICAL DEVICES) REGULATIONS 2002

DECLARATION OF CONFORMITY PROCEDURES

This is a declaration of conformity made under clause 6.6 of Schedule 3 to the Therapeutic Goods (Medical Devices) Regulations 2002.

Manufacturer's name:

Business address:

Medical device(s):

Welch Allyn, Inc.

4341 State Street Road Skaneateles Falls, NY 13153-0220 U.S.A.

Welch Allyn FlexiPortrM Blood Pressure Cuffs REF: 901043 BLOOD PRESSURE CUFF, REUSEABLE

901044 BLOOD PRESSURE CUFF, DISPOSABLE

Welch Allyn FlexiPort'M Blood Pressure Cuffs- REUSE Series

m Description

REUSE-06 CUFF, WA, REUSABLE, SMALL INFA REUSE-06-1HP CUFF, REUS, SM INFANT, 1-TUBE, REUSE-06-1MQ CUFF, REUS, SM INFANT, 1-TUBE, REUSE-06-1SC CUFF, REUS, SM INFANT, 1-TUBE, REUSE-06-1 TP CUFF, REUS, SM INFANT, 1-TUBE, REUSE-06-1 TPE CUFF, REUS, SM INFANT, 1-TUBE REUSE-07 CUFF, WA, REUSABLE, INFANT REUSE-07 -1HP CUFF, REUS, INFANT, 1-TUBE, HP REUSE-07-1MQ CUFF, REUS, INFANT, 1-TUBE, MQ REUSE-07 -1SC CUFF, REUS, INFANT, 1-TUBE, SC REUSE-07 -1 TP CUFF, REUS, INFANT, 1-TUBE, TP REUSE-07 -1 TPE CUFF, REUS, INFANT, 1-TUBE TPE REUSE-07-2BV CUFF, REUS, INFANT, 2-TUBE, BV REUSE-07-2BVC CUFF, REUS, INFANT, 2-TUBE, BV REUSE-07-2MF CUFF, REUS, INFANT, 2-TUBE, MF REUSE-07-2MQ CUFF, REUS, INFANT, 2-TUBE, MQ REUSE-07-2SC CUFF, REUS, INFANT, 2-TUBE, SC REUSE-07-2TP CUFF, REUS, INFANT, 2-TUBE, TP REUSE-07-2TPE CUFF, REUS, INFANT, 2-TB, TPE REUSE-08 CUFF, WA, REUSABLE, SM CHILD REUSE-08-1HP CUFF, REUS SM CHILD 1-TUBE, HP REUSE-08-1MQ CUFF, REUS SM CHILD 1-TUBE, MQ REUSE-08-1SC CUFF, REUS SM CHILD 1-TUBE, SC REUSE-08-1 TP CUFF, REUS SM CHILD 1-TUBE, TP REUSE-08-1 TPE CUFF, REUS SM CHILD 1-TUBE TPE REUSE-08-2BV CUFF, REUS SM CHILD 2-TUBE, BV

4341 State Street Road, Skaneateles Falls, NY 13153

www.welchallyn.com Enhanci ng outcomes for • : M 1 Cl" ( 1 patients and their caregivers: C. i' P Template DIR 80019263 Ver. C

Welc~Miyn·

m REUSE-06 REUSE-08-2BVC REUSE-08-2MF REUSE-08-2MQ REUSE-08-2SC REUSE-08-2TP REUSE-08-2TPE REUSE-09 REUSE-09-1HP REUSE-09-1MQ REUSE-09-1SC REUSE-09-1 TP REUSE-09-1 TPE REUSE-09-2BV REUSE-09-2BVC REUSE-09-2MF REUSE-09-2MQ REUSE-09-2SC REUSE-09-2TP REUSE-09-2TPE REUSE-10 REUSE-1 0-1HP REUSE-10-1MQ REUSE-1 0-1SC REUSE-1 0-1 TP REUSE-10-1 TPE REUSE-10-2BV REUSE-10-2BVC REUSE-10-2MF REUSE-10-2MQ REUSE-10-2SC REUSE-1 0-2TP REUSE-1 0-2TPE REUSE-11 REUSE-11-1HP REUSE-11-1MQ REUSE-11-1SC REUSE-11-1 TP REUSE-11-1 TPE REUSE-11-2BV REUSE-11-2BVC REUSE-11-2MF REUSE-11-2MQ REUSE-11-2SC REUSE-11-2TP


www.wefchallyn.com Template DIR 80019263 Ver. C

SAP DIR: 80020273 Version: C Page 2 oflO

Description

CUFF, WA, REUSABLE, SMALL INFA CUFF, REUS SM CHILD 2-TUBE, BV CUFF, REUS SM CHILD 2-TUBE MF CUFF, REUS SM CHILD 2-TUBE, MQ CUFF, REUS SM CHILD 2-TUBE, SC CUFF, REUS SM CHILD 2-TUBE, TP CUFF, REUS SM CHILD 2-TB, TPE CUFF, WA, REUSABLE, CHILD CUFF, REUS, CHILD, 1-TUBE, HP CUFF, REUS, CHILD, 1-TUBE, MQ CUFF, REUS, CHILD, 1-TUBE, SC CUFF, REUS, CHILD, 1-TUBE, TP CUFF, REUS, CHILD, 1-TUBE, TPE CUFF, REUS, CHILD, 2-TUBE, BV CUFF, REUS, CHILD, 2-TUBE, BVC CUFF, REUS, CHILD, 2-TUBE MF CUFF, REUS, CHILD, 2-TUBE, MQ CUFF, REUS, CHILD, 2-TUBE, SC CUFF, REUS, CHILD, 2-TUBE, TP CUFF, REUS, CHILD, 2-TUBE, TPE CUFF, WA, REUSABLE, SMADULT CUFF, REUS, SM AD, 1-TUBE, HP CUFF, REUS, SM AD, 1-TUBE, MQ CUFF, REUS, SM AD, 1-TUBE, SC CUFF, REUS, SM AD, 1-TUBE, TP CUFF, REUS, SM AD, 1-TUBE, TPE CUFF, REUS, SM AD, 2-TUBE, BV CUFF, REUS, SM AD, 2-TUBE, BVC CUFF, REUS, SM AD, 2-TUBE, MF CUFF, REUS, SM AD, 2-TUBE, MQ CUFF, REUS, SM AD, 2-TUBE, SC CUFF, REUS, SM AD, 2-TUBE, TP CUFF, REUS, SM AD, 2-TUBE, TPE CUFF, WA, REUSABLE, ADULT CUFF, REUS, ADULT, 1-TUBE, HP CUFF, REUS, ADULT, 1-TUBE, MQ CUFF, REUS, ADULT, 1-TUBE, SC CUFF, REUS, ADULT, 1-TUBE, TP CUFF, REUS, ADULT, 1-TUBE, TPE CUFF, REUS, ADULT, 2-TUBE, BV CUFF, REUS, ADULT, 2-TUBE, BVC CUFF, REUS, ADULT, 2-TUBE, MF CUFF, REUS, ADULT, 2-TUBE, MQ CUFF, REUS, ADULT, 2-TUBE, SC CUFF, REUS, ADULT, 2-TUBE, TP

Enhancing outcomes for 1 : M 1 =! patients and their caregivers: t<N f I P

Welc~Miyn·

m REUSE-06 REUSE-11-2TPE REUSE-11C REUSE-11L REUSE-11L-1HP REUSE-11L-1MQ REUSE-11L-1SC REUSE-11L-1TP REUSE-11L-1 TPE REUSE-11L-2BV REUSE-11L-2BVC REUSE-11L-2MF REUSE-11L-2MQ REUSE-11L-2SC REUSE-11L-2TP REUSE-11L-2TPE REUSE-12 REUSE-12-1HP REUSE-12-1MQ REUSE-12-1SC REUSE-12-1 TP REUSE-12-1 TPE REUSE-12-2BV REUSE-12-2BVC REUSE-12-2MF REUSE-12-2MQ REUSE-12-2SC REUSE-12-2TP REUSE-12-2TPE REUSE-12L REUSE-12L-1HP REUSE-12L-1MQ REUSE-12L-1SC REUSE-12L-1 TP REUSE-12L-1 TPE REUSE-12L-2BV REUSE-12L-2BVC REUSE-12L-2MF REUSE-12L-2MQ REUSE-12L-2SC REUSE-12L-2TP REUSE-12L-2TPE REUSE-13 REUSE-13-1HP REUSE-13-1MQ


www.welchallyn.com Template DIR 80019263 Ver. C


Description

CUFF, WA, REUSABLE, SMALL INFA CUFF, REUS, ADULT, 2-TUBE, TPE REUSE-11 NIBP CUFF FOR CHINA CUFF, WA, REUSABLE ADULT LONG CUFF, REUS, AD LONG 1-TUBE, HP CUFF, REUS, AD LONG 1-TUBE, MQ CUFF, REUS, AD LONG 1-TUBE, SC CUFF, REUS, AD LONG 1-TUBE, TP CUFF, REUS, AD LONG 1-TUBE TPE CUFF, REUS, AD LONG 2-TUBE, BV CUFF, REUS, AD LONG 2-TUBE, BV CUFF, REUS, AD LONG 2-TUBE, MF CUFF, REUS, AD LONG 2-TUBE, MQ CUFF, REUS, AD LONG 2-TUBE, SC CUFF, REUS, AD LONG 2-TUBE, TP CUFF, REUS, AD LONG 2-TUBE TPE CUFF, WA, REUSABLE, LG ADULT CUFF, REUS, LGAD, 1-TUBE, HP CUFF, REUS, LG AD, 1-TUBE, MQ REUS, LG AD, 1-TUBE, SC CUFF, REUS, LG AD, 1-TUBE, TP CUFF, REUS, LG AD, 1-TUBE, TPE CUFF, REUS, LG AD, 2-TUBE, BV CUFF, REUS, LG AD, 2-TUBE, BVC CUFF, REUS, LG AD, 2-TUBE, MF CUFF, REUS, LG AD, 2-TUBE, MQ CUFF, REUS, LG AD, 2-TUBE, SC CUFF, REUS, LG AD, 2-TUBE, TP CUFF, REUS, LG AD, 2-TUBE, TPE CUFF, WA, REUS, LG ADULT LONG CUFF REUS LG AD LONG 1-TUBE HP CUFF REUS LG AD LONG 1-TUBE MQ CUFF REUS LG AD LONG 1-TUBE SC CUFF REUS LG AD LONG 1-TUBE TP CUFF REUS LG AD LONG 1-TUBE TP CUFF REUS LG AD LONG 2-TUBE BV CUFF REUS LG AD LONG 2-TUBE BV CUFF REUS LG AD LONG 2-TUBE MF CUFF REUS LG AD LONG 2-TUBE MQ CUFF REUS LG AD LONG 2-TUBE SC CUFF REUS LG AD LONG 2-TUBE TP CUFF REUS LG AD LONG 2-TUBE TP CUFF, WA, REUSABLE, THIGH CUFF, REUS, THIGH, 1-TUBE, HP CUFF, REUS, THIGH, 1-TUBE, MQ

Enhancing outcomes for 1 : t11 = • patients and the ir caregivers: b{ •] i I P

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rn REUSE-06 REUSE-13-1SC REUSE-13-1 TP REUSE-13-1 TPE REUSE-13-2BV REUSE-13-2BVC REUSE-13-2MF REUSE-13-2MQ REUSE-13-2SC REUSE-13-2TP REUSE-13-2TPE REUSE-ACC-MON REUSE-FP-BV REUSE-FP-HAND REUSE-FP-MON REUSE-MLT REUSE-MLT-1 REUSE-MLT-2 REUSE-PED-BV REUSE-PED-HAND REUSE-PED-MON 405190 405192 405240 405242 405260 410519 412942


Description

CUFF, WA, REUSABLE, SMALL INFA CUFF, REUS, THIGH, 1-TUBE, SC CUFF, REUS, THIGH, 1-TUBE, TP CUFF, REUS, THIGH, 1-TUBE, TPE CUFF, REUS, THIGH, 2-TUBE, BV CUFF, REUS, THIGH, 2-TUBE, BVC CUFF, REUS, THIGH, 2-TUBE, MF CUFF, REUS, THIGH, 2-TUBE, MQ CUFF, REUS, THIGH, 2-TUBE, SC CUFF, REUS, THIGH, 2-TUBE, TP CUFF, REUS, THIGH, 2-TUBE, TPE CUFF, REUSE(CHILD,SM ADULT,THI CUFF, REUSE, FP WALL PACK CUFF, REUSE, FP HAND GAUGE PAC CUFF,REUSE, FP MONITOR PACK CUFF, REUS, MULTIPACK CUFF,REUSE,ADULT MULTIPACK,1-T CUFF,REUSE,ADULT MULTIPACK,2-T CUFF, REUSE, PED WALL PACK CUFF, REUSE, PED HAND GAUGE PA CUFF, REUSE, PED MONITOR PACK CUFF, REUSE, AD + LG AD, 1 TB S CUFF, REUSE, AD + LG AD, 2TB M CUFF, REUSE,CHILD,AD,LG AD, 1 T CUFF,REUSE,CHILD,AD,LGAD,THIGH CUFF, REUSE, CHILD, 2-TUBE, TP CUFF KIT CUFF KIT, PHYSICIANS OFFICE

Welch Allyn FlexiPort™ Blood Pressure Cuffs- SOFT Series

rn SOFT-06 SOFT-06-1HP SOFT-06-1MQ SOFT -06-1SC SOFT-06-1 TP SOFT -06-1 TPE SOFT-07 SOFT-07-1HP SOFT-07-1MQ SOFT-07-1SC SOFT-07-1 TP SOFT-07-1 TPE SOFT-07-2BV

4341 State St reet Road, Skaneateles Falls, NY 13153


Description

CUFF,WA,SOFT, SMALL INFANT CUFF, SOFT, SM INFANT, 1-TUBE, CUFF, SOFT, SM INFANT, 1-TUBE, CUFF, SOFT, SM INFANT, 1-TUBE, CUFF, SOFT, SM INFANT, 1-TUBE, CUFF, SOFT, SM INFANT, 1-TUBE, CUFF, WA, SOFT, INFANT CUFF, SOFT, INFANT, 1-TUBE, HP CUFF, SOFT, INFANT, 1-TUBE, MQ CUFF, SOFT, INFANT, 1-TUBE, SC CUFF, SOFT, INFANT, 1-TUBE, TP CUFF, SOFT, INFANT, 1-TUBE, TP CUFF, SOFT, INFANT, 2-TUBE, BV

Enhancing outcomes for 1 : N 1 =! patients and their caregive rs: * •) i I P

Welc~Allyn·

m SOFT-06 SOFT-07-2BVC SOFT-07-2MF SOFT-07-2MQ SOFT-07-2SC SOFT-07-2TP SOFT-07-2TPE SOFT-08 SOFT -08-1HP SOFT-08-1MQ SOFT -08-1SC SOFT-08-1 TP SOFT-08-1TPE SOFT-08-2BV SOFT-08-2BVC SOFT-08-2MF SOFT-08-2MQ SOFT-08-2SC SOFT-08-2TP SOFT-08-2TPE SOFT-09 SOFT-09-1HP SOFT-09-1MQ SOFT -09-1SC SOFT-09-1 TP SOFT-09-1TPE SOFT-09-2BV SOFT-09-2BVC SOFT-09-2MF SOFT-09-2MQ SOFT-09-2SC SOFT-09-2SCC SOFT-09-2TP SOFT-09-2TPE SOFT-10 SOFT-10-1HP SOFT-10-1MQ SOFT-10-1SC SOFT-10-1TP SOFT-10-1TPE SOFT -10-2BV SOFT-10-2BVC SOFT-10-2MF SOFT-10-2MQ SOFT-10-2SC



SAP DIR: 80020273 Version: C Page 5 of10

Description

CUFF,WA,SOFT, SMALL INFANT CUFF, SOFT, INFANT, 2-TUBE, BV CUFF, SOFT, INFANT, 2-TUBE, MF CUFF, SOFT, INFANT, 2-TUBE, MQ CUFF, SOFT, INFANT, 2-TUBE, SC CUFF, SOFT, INFANT, 2-TUBE, TP CUFF, SOFT, INFANT, 2-TUBE TPE CUFF, WA, SOFT, SMALL CHILD CUFF, SOFT SM CHILD 1-TUBE, HP CUFF, SOFT SM CHILD 1-TUBE, MQ CUFF, SOFT SM CHILD 1-TUBE, SC CUFF, SOFT SM CHILD 1-TUBE, TP CUFF, SOFT, SM CHILD 1-TUBE, T CUFF, SOFT SM CHILD 2-TUBE, BV CUFF, SOFT SM CHILD 2-TUBE, BV CUFF, SOFT, SM CHILD, 2-TUBE, CUFF, SOFT SM CHILD 2-TUBE, MQ CUFF, SOFT SM CHILD 2-TUBE, SC CUFF, SOFT SM CHILD 2-TUBE, TP CUFF, SOFT SM CHILD 2-TUBE TPE CUFF, WA, SOFT, CHILD CUFF, SOFT, CHILD, 1-TUBE, HP CUFF, SOFT, CHILD, 1-TUBE, MQ CUFF, SOFT, CHILD, 1-TUBE, SC CUFF, SOFT, CHILD, 1-TUBE, TP CUFF, SOFT, CHILD, 1-TUBE, TPE CUFF, SOFT, CHILD, 2-TUBE, BV CUFF, SOFT, CHILD, 2-TUBE, BVC CUFF, SOFT, CHILD, 2-TUBE, MF CUFF, SOFT, CHILD, 2-TUBE, MQ CUFF, SOFT, CHILD, 2-TUBE, SC CUFF, SOFT, CHILD, 2-TUBE, SCC CUFF, SOFT, CHILD, 2-TUBE, TP CUFF, SOFT, CHILD, 2-TUBE, TPE CUFF, W A, SOFT, SMALL ADULT CUFF, SOFT, SM AD, 1-TUBE, HP CUFF, SOFT, SM AD, 1-TUBE, MQ CUFF, SOFT, SM AD, 1-TUBE, SC CUFF, SOFT, SM AD, 1-TUBE, TP CUFF, SOFT, SM AD, 1-TUBE, TPE CUFF, SOFT, SM AD, 2-TUBE, BV CUFF, SOFT, SM AD, 2-TUBE, BVC CUFF, SOFT, SM AD, 2-TUBE, MF CUFF, SOFT, SM AD, 2-TUBE, MQ CUFF, SOFT, SM AD, 2-TUBE, SC

Enhancing outcomes for 1: N 1 = • ( ~ l patients and their caregivers: b e f' p

Welc~ADyn·

[I] SOFT-06 SOFT-10-2SCC SOFT-10-2TP SOFT-10-2TPE SOFT-11 SOFT-11-1HP SOFT-11-1MQ SOFT-11-1SC SOFT-11-1 TP SOFT-11-1 TPE SOFT-11-2BV SOFT-11-2BVC SOFT-11-2MF SOFT-11-2MQ SOFT-11-2SC SOFT-11-2SCC SOFT-11-2TP SOFT-11-2TPE SOFT-11L SOFT-11L-1HP SOFT-11L-1MQ SOFT-11L-1SC SOFT-11L-1 TP SOFT-11L-1 TPE SOFT-11L-2BV SOFT-11L-2BVC SOFT-11L-2MF SOFT-11L-2MQ SOFT-11L-2SC SOFT-11L-2TP SOFT-11L-2TPE SOFT-12 SOFT-12-1HP SOFT-12-1MQ SOFT-12-1SC SOFT-12-1TP SOFT-12-1TPE SOFT-12-2BV SOFT-12-2BVC SOFT-12-2MF SOFT-12-2MQ SOFT-12-2SC SOFT-12-2SCC SOFT-12-2TP SOFT-12-2TPE



SAP DJR: 80020273 Version: C Page 6 oflO

Description CUFF,WA,SOFT, SMALL INFANT CUFF SOFT SM ADULT 2-TUBE, SCC CUFF, SOFT, SM AD, 2-TUBE, TP CUFF, SOFT, SM AD, 2-TUBE, TPE CUFF, WA,SOFT,ADULT CUFF, SOFT, ADULT, 1-TUBE, HP CUFF, SOFT, ADULT, 1-TUBE, MQ CUFF, SOFT, ADULT, 1-TUBE, SC CUFF, SOFT, ADULT, 1-TUBE, TP CUFF, SOFT, ADULT, 1-TUBE, TPE CUFF, SOFT, ADULT, 2-TUBE, BV CUFF, SOFT, ADULT, 2-TUBE, BVC CUFF, SOFT, ADULT, 2-TUBE, MF CUFF, SOFT, ADULT, 2-TUBE, MQ CUFF, SOFT, ADULT, 2-TUBE, SC CUFF, SOFT, ADULT, 2-TUBE, SCC CUFF, SOFT, ADULT, 2-TUBE, TP CUFF, SOFT, ADULT, 2-TUBE, TPE CUFF, WA, SOFT, ADULT LONG CUFF, SOFT, AD LONG 1-TUBE, HP CUFF, SOFT, AD LONG 1-TUBE, MQ CUFF, SOFT, AD LONG 1-TUBE, SC CUFF, SOFT, AD LONG 1-TUBE, TP CUFF, SOFT, AD LONG, 1-TUBE, T CUFF, SOFT, AD LONG 2-TUBE, BV CUFF, SOFT, AD LONG 2-TUBE, BV CUFF, SOFT, AD LONG, 2-TUBE, M CUFF, SOFT, AD LONG 2-TUBE, MQ CUFF, SOFT, AD LONG 2-TUBE, SC CUFF, SOFT, AD LONG 2-TUBE, TP CUFF, SOFT, AD LONG 2-TUBE TPE CUFF, WA, SOFT, LG ADULT CUFF, SOFT, LG AD, 1-TUBE, HP CUFF, SOFT, LG AD, 1-TUBE, MQ CUFF, SOFT, LG AD, 1-TUBE, SC CUFF, SOFT, LG AD, 1-TUBE, TP CUFF, SOFT, LG AD, 1-TUBE, TPE CUFF, SOFT, LG AD, 2-TUBE, BV CUFF, SOFT, LG AD, 2-TUBE, BVC CUFF, SOFT,LG AD, 2-TUBE, MF CUFF, SOFT, LG AD, 2-TUBE, MQ CUFF, SOFT, LG AD, 2-TUBE, SC CUFF, SOFT, LG AD, 2-TUBE, SCC CUFF, SOFT, LG AD, 2-TUBE, TP CUFF, SOFT, LG AD, 2-TUBE, TPE

Enhancing outcomes for 1 : M 1 ~ a {I 1 J pat ients and their caregivers: :• UP

Welc~f\llrn·

m SOFT-06 SOFT-12L SOFT -12L-1HP SOFT-12L-1MQ SOFT -12L-1SC SOFT-12L-1 TP SOFT-12L-1 TPE SOFT-12L-2BV SOFT -12L-2BVC SOFT-12L-2MF SOFT-12L-2MQ SOFT-12L-2SC SOFT-12L-2TP SOFT-12L-2TPE SOFT-13 SOFT-13-1HP SOFT-13-1MQ SOFT-13-1SC SOFT-13-1TP SOFT-13-1TPE SOFT-13-2BV SOFT-13-2BVC SOFT-13-2MF SOFT-13-2MQ SOFT-13-2SC SOFT-13-2SCC SOFT-13-2TP SOFT-13-2TPE SOFT-MLT SOFT-MLT-1 SOFT-MLT-2 VSOFT-09 VSOFT-10 VSOFT-11 VSOFT-11L VSOFT-12 VSOFT-12L


Description

CUFF,WA,SOFT, SMALL INFANT CUFF, WA, SOFT, LG ADULT LONG CUFF SOFT LG AD LONG 1-TUBE HP CUFF SOFT LG AD LONG 1-TUBE MQ CUFF SOFT LG AD LONG 1-TUBE SC CUFF SOFT LG AD LONG 1-TUBE TP CUFF, SOFT, LG AD LONG, 1-TUBE CUFF SOFT LG AD LONG 2-TUBE BV CUFF SOFT LG AD LONG 2-TUBE BV CUFF, SOFT, LG AD LONG, 2-TU CUFF SOFT LG AD LONG 2-TUBE MQ CUFF SOFT LG AD LONG 2-TUBE SC CUFF SOFT LG AD LONG 2-TUBE TP CUFF SOFT LGAD LONG 2-TUBE TPE CUFF, WA, SOFT, THIGH CUFF, SOFT, THIGH, 1-TUBE, HP CUFF, SOFT, THIGH, 1-TUBE, MQ CUFF, SOFT, THIGH, 1-TUBE, SC CUFF, SOFT, THIGH, 1-TUBE, TP CUFF, SOFT, THIGH, 1-TUBE, TPE CUFF, SOFT, THIGH, 2-TUBE, BV CUFF, SOFT, THIGH, 2-TUBE, BVC CUFF, SOFT, THIGH, 2-TUBE, MF CUFF, SOFT, THIGH, 2-TUBE, MQ CUFF, SOFT, THIGH, 2-TUBE, SC CUFF, SOFT, THIGH, 2-TUBE, SCC CUFF, SOFT, THIGH, 2-TUBE, TP CUFF, SOFT, THIGH, 2-TUBE, TPE CUFF, SOFT, MULTIPACK CUFF,SOFT,ADULT MULTIPACK,1-TB CUFF,SOFT,ADULT MULTIPACK,2-TB NOVAPLUS RAW CUFF SOFT CHILD NOVAPLUS RAW CUFF SOFT SMALL A NOVAPLUS RAW CUFF SOFT ADULT NOVAPLUS RAW CUFF SOFT ADULT L NOVAPLUS RAW CUFF SOFT LG ADUL NOVAPLUS RAW CUFF SOFT LG ADUL

Welch Allyn FlexiPort™ Blood Pressure Cuffs- VINYL Series

m VINYL-06 VINYL-06-1HP VINYL-06-1MQ VINYL-06-1SC


www. welchallyn.com Template DIR 80019263 Ver. C

Description

CUFF, W A, VINYL, SMALL INFANT CUFF, VINYL SM INFANT, 1-TUBE, CUFF, VINYL SM INFANT, 1-TUBE, CUFF, VINYL SM INFANT, 1-TUBE,

Enhancing outcomes for 1: M 1 C.[ patients and their caregivers: b{ •1 f I P

Welc~Mlyn~

[]] VINYL-06 VINYL-07 VINYL-07-1HP VINYL-07-1MQ VINYL-07-1SC VINYL-07-2BV VINYL-07-2BVC VINYL-07-2MQ VINYL-07-2SC VINYL-08 VINYL-08-1HP VINYL-08-1MQ VINYL-08-1SC VINYL-08-2BV VINYL-08-2BVC VINYL-08-2MQ VINYL-08-2SC VINYL-09 VINYL-09-1HP VINYL-09-1MQ VINYL-09-1SC VINYL-09-2BV VINYL-09-2BVC VINYL-09-2MQ VINYL-09-2SC VINYL-10 VINYL-10-1HP VINYL-10-1MQ VINYL-10-1SC VINYL-10-2BV VINYL-10-2BVC VINYL-10-2MQ VINYL-10-2SC VINYL-11 VINYL-11-1HP VINYL-11-1MQ VINYL-11-1SC VINYL-11-2BV VINYL-11-2BVC VINYL-11-2MQ VINYL-11-2SC VINYL-11L VINYL-11L-1HP VINYL-11L-1MQ VINYL-11L-1SC



SAP DIR: 80020273 Version: C Page 8 of 10

Description

CUFF, WA, VINYL, SMALL INFANT CUFF, WA, VINYL INFANT CUFF, VINYL INFANT, 1-TUBE, HP CUFF, VINYL INFANT, 1-TUBE, MQ CUFF, VINYL INFANT, 1-TUBE, SC CUFF, VINYL INFANT, 2-TUBE, BV CUFF, VINYL INFANT, 2-TUBE, BV CUFF, VINYL INFANT, 2-TUBE, MQ CUFF, VINYL INFANT, 2-TUBE, SC CUFF, WA, VINYL SM CHILD CUFF, VINYL SM CHILD 1-TUBE HP CUFF, VINYL SM CHILD 1-TUBE MQ CUFF, VINYL SM CHILD 1-TUBE SC CUFF, VINYL SM CHILD 2-TUBE BV CUFF, VINYL SM CHILD 2-TUBE BV CUFF, VINYL SM CHILD 2-TUBE MQ CUFF, VINYL SM CHILD 2-TUBE SC CUFF, W A, VINYL CHILD CUFF, VINYL CHILD, 1-TUBE, HP CUFF, VINYL CHILD, 1-TUBE, MQ CUFF, VINYL CHILD, 1-TUBE, SC CUFF, VINYL CHILD, 2-TUBE, BV CUFF, VINYL CHILD, 2-TUBE, BVC CUFF, VINYL CHILD, 2-TUBE, MQ CUFF, VINYL CHILD, 2-TUBE, SC CUFF, W A, VINYL, SM AD CUFF, VINYL, SM AD, 1-TUBE, HP CUFF, VINYL, SM AD, 1-TUBE, MQ CUFF, VINYL, SM AD, 1-TUBE, SC CUFF, VINYL, SM AD, 2-TUBE, BV CUFF, VINYL, SM AD, 2-TUBE, BV CUFF, VINYL, SM AD, 2-TUBE, MQ CUFF, VINYL, SM AD, 2-TUBE, SC CUFF, WA, VINYL ADULT CUFF, VINYL ADULT, 1-TUBE, HP CUFF, VINYL ADULT, 1-TUBE, MQ CUFF, VINYL ADULT, 1-TUBE, SC CUFF, VINYL ADULT, 2-TUBE, BV CUFF, VINYL ADULT, 2-TUBE, BVC CUFF, VINYL ADULT, 2-TUBE, MQ CUFF, VINYL ADULT, 2-TUBE, SC CUFF, WA, VINYL, ADULT LONG CUFF, VINYL AD LONG 1-TUBE, HP CUFF, VINYL AD LONG 1-TUBE, MQ CUFF, VINYL AD LONG 1-TUBE, SC

Enhancing outcomes for • : N 1 = .[ patients and t heir caregivers: t{ •) f I P

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m VINYL-06 VINYL-11L-2BV VINYL-11L-2BVC VINYL-11L-2MQ VINYL-11L-2SC VINYL-12 VINYL-12-1HP VINYL-12-1MQ VINYL-12-1SC VINYL-12-2BV VINYL-12-2BVC VINYL-12-2MQ VINYL-12-2SC VINYL-12L VINYL-12L-1HP VINYL-12L-1MQ VINYL-12L-1SC VINYL-12L-2BV VINYL-12L-2BVC VINYL-12L-2MQ VINYL-12L-2SC VINYL-13 VINYL-13-1HP VINYL-13-1MQ VINYL-13-1SC VINYL-13-2BV VINYL-13-2BVC VINYL-13-2MQ VINYL-13-2SC VINYL-MLT

Classification:


Description CUFF, WA, VINYL, SMALL INFANT CUFF, VINYL AD LONG 2-TUBE, BV CUFF, VINYL AD LONG 2-TUBE, BV CUFF, VINYL AD LONG 2-TUBE, MQ CUFF, VINYL AD LONG 2-TUBE, SC CUFF, W A, VINYL LG AD CUFF, VINYL LG AD, 1-TUBE, HP CUFF, VINYL LG AD, 1-TUBE, MQ CUFF, VINYL LG AD, 1-TUBE, SC CUFF, VINYL LG AD, 2-TUBE, BV CUFF, VINYL LG AD, 2-TUBE, BVC CUFF, VINYL LG AD, 2-TUBE, MQ CUFF, VINYL LG AD, 2-TUBE, SC CUFF, WA, VINYL, LG ADULT LONG CUFF VINYL LG AD LONG 1-TUBE H CUFF VINYL LG AD LONG 1-TUBE M CUFF VINYL LG AD LONG 1-TUBE S CUFF VINYL LG AD LONG 2-TUBE B CUFF VINYL LG AD LONG 2-TUBE B CUFF VINYL LG AD LONG 2-TUBE M CUFF VINYL LG AD LONG 2-TUBES CUFF, WA, VINYL THIGH CUFF, VINYL THIGH, 1-TUBE, HP CUFF, VINYL THIGH, 1-TUBE, MQ CUFF, VINYL THIGH, 1-TUBE, SC CUFF, VINYL THIGH, 2-TUBE, BV CUFF, VINYL THIGH, 2-TUBE, BVC CUFF, VINYL THIGH, 2-TUBE, MQ CUFF, VINYL THIGH, 2-TUBE, SC CUFF, VINYL, MULTIPACK

GMDN code and term: 34978 - Cuff, Blood Pressure, reusable

Scope of application: All

Each kind of medical device to which the technical documentation applies complies with the applicable provisions of the essential principles and the classification rules before being supplied.

Standards applied: Standard I Version

I


www. welchallyn.com Template DIR 80019263 Ver. C

Title <Please give details of any conformity assessment standard or medical device standard that has been

Enhancing outcomes for 1 : M 1 = f l patients and their caregivers: * •] i I P

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Standards applied: Standard 1 Version

EN ISO 13485 2012

-------1 EN ISO 14971 2012

I ~N/ISO 81060- 2012

I EN ISO 10993-1 2009

I ISO 15223-1 2012

I

EN 980 ! 2008

EN 1041 l 2oo8 I

Authorised signatory:



Title

SAP DIR: 80020273 Version: C Page 10 of 10

applied to the kind of medical device; OR See Attached Schedule for multiple standards>

Medical devices - Quality management systems - Requirements for regulatory purpose£

; Medical devices - Application of risk ; management to medical devices l Non-invasive sphygmomanometers' 1 Part 1: Requirements and test methods I for non-automated measurement type. I Biological evaluation of medical devices ! -Part 1: Evaluation and testing ! Medical devices - Symbols to be used . with ' medical device labels, labelling and

information to be supplied- Part 1: . General requirements (ISO 15223-

1:2012) Graphical symbols for use in the la~e!ling of medical devices Information supplied by the manufacturer with medical devices

Enhancing outcomes for 1: H 1• • patients and their caregivers: H tit{ • ] i ., p

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