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Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
Ophthalmic/otologic diagnostic set FDA UDI
Device Name
Welch Allyn Ambulatory Blood Pressure Cuff Kit; Small Adult, and Adult Plus; Reusable Sleeve Style Qty. 2 FDA UDI
Model / Reference
901097 FDA UDI
Description
Welch Allyn Ambulatory Blood Pressure Cuff Kit; Small Adult, and Adult Plus; Reusable Sleeve Style Qty. 2 FDA UDI

Identifiers

Catalog Number
101490 FDA UDI
Primary DI / UDI-DI
00732094069877 FDA UDI
510(k) Number
K072449 FDA UDI
FDA Product Code
BZG FDA UDI
GMDN Term
Ophthalmic/otologic diagnostic set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ophthalmic/otologic diagnostic set

Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic/otologic diagnostic set.

Cleared under the same submission

K072449 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welch Allyn, Inc.

Sources (1)

  • FDA UDI c327bc8d-ed2e-49b2-90ba-0e70e09efe1b 36 fields · synced May 31, 2026