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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
ASSY CD ROM & COVER CPWS WEBSTATION 1.0 FDA UDI
Model / Reference
901047 FDA UDI
Description
ASSY CD ROM & COVER CPWS WEBSTATION 1.0 FDA UDI

Identifiers

Catalog Number
404091 FDA UDI
Primary DI / UDI-DI
00732094050615 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

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 cde63ffe-9103-4f26-a2b0-3b15d9f124d8 36 fields · synced May 30, 2026