WELCH ALLYN, INC.

Address:7865 NORTH 86TH ST.,MILWAUKEE,WI,53224,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Anoscope and accessories (FER) (7) DURA SUBSTITUTE (GXQ) (2) blood pressure cuff (DXQ) (1)

Premarket Exempt

No Yes

Clear

Welch Allyn, Inc. - 00732094007596 Catalog Number : 380067-501

Device Description : SML OBTURATOR ASSY W O SPACER

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : No

Device Count : 1

Welch Allyn, Inc. - 00732094007602 Catalog Number : 380066-501

Device Description : 14MM OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007619 Catalog Number : 380065-501

Device Description : MEDIUM OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : No

Device Count : 1

Welch Allyn, Inc. - 00732094007626 Catalog Number : 380040-504

Device Description : PREMATURE OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007633 Catalog Number : 380035-502

Device Description : LARGE OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : No

Device Count : 1

Welch Allyn, Inc. - 00732094007640 Catalog Number : 370056-503

Device Description : OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007664 Catalog Number : 370056-501

Device Description : OBTURATOR ASSY

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : FER

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007695 Catalog Number : 3659CK

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Three-Cuff Kit: Child, Adult, and Larg Welch Allyn Trimline Blood Pressure Cuff; Three-Cuff Kit: Child, Adult, and Large Adult; Reusable, 2-Tubes (10.0 in/25.4 cm), Female Screw (#5082-164) Connectors; Qty. 3

Device Class : 2

Duns Number: 198227881

Premarket Exempt : Yes

Product Code : GXQ

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007701 Catalog Number : 3657HP

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Four-Cuff Kit: Infant, Child, Small Ad Welch Allyn Trimline Blood Pressure Cuff; Four-Cuff Kit: Infant, Child, Small Adult, and Adult; Reusable, 1-Tube (10.0 in/25.4 cm), Male Bayonet (#5082-184) Connector; Qty. 4

Device Class : 2

Duns Number: 198227881

Premarket Exempt : Yes

Product Code : GXQ

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094007725 Catalog Number : 3655CK

Device Description : Welch Allyn Trimline Blood Pressure Cuff; Six-Cuff Kit: Infant, Child, Small Adu Welch Allyn Trimline Blood Pressure Cuff; Six-Cuff Kit: Infant, Child, Small Adult, Adult, Large Adult, Thigh; Reusable, 2-Tubes (10.0 in/25.4 cm), Female Screw (#5082-164) Connectors; Qty. 6

Device Class : 2

Duns Number: 198227881

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

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