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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
Electrocardiograph, professional, multichannel FDA UDI
Device Name
Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer FDA UDI
Model / Reference
901052 FDA UDI
Description
Welch Allyn PCH-100 Holter Office Software Kit including HR-100 Holter Recorder, 7-Lead AHA Cable, Laptop Computer, Printer FDA UDI

Identifiers

Catalog Number
100711 FDA UDI
Primary DI / UDI-DI
00732094070729 FDA UDI
510(k) Number
K051730 FDA UDI
FDA Product Code
MLR FDA UDI
GMDN Term
Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6860 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

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

Cleared under the same submission

K051730 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 9b1eaf45-5601-4f00-9c02-2cc342c8c608 37 fields · synced May 31, 2026