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: BUR250c 12-Lead Multi-Channel Electrocardiograph - Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module; current software, Adult and Pediatric Interpretation, Standard storage (up to 40 ECGs), LAN + WLAN; International power cord, IEC 10 wire, 12-lead lead set with banana plugs, ECG clip adapters (set of 10) and Mortara tab electrodes (pouch of 100), starter pack A4 paper with spacer for writer tray FDA UDI
Model / Reference: 901131 FDA UDI
Description: BUR250c 12-Lead Multi-Channel Electrocardiograph - Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module; current software, Adult and Pediatric Interpretation, Standard storage (up to 40 ECGs), LAN + WLAN; International power cord, IEC 10 wire, 12-lead lead set with banana plugs, ECG clip adapters (set of 10) and Mortara tab electrodes (pouch of 100), starter pack A4 paper with spacer for writer tray FDA UDI

Identifiers

Catalog Number: BUR250C-82X FDA UDI
Primary DI / UDI-DI: 00732094271713 FDA UDI
510(k) Number: K101403 FDA UDI
FDA Product Code: DPS FDA UDI
GMDN Term: Electrocardiograph, professional, multichannel FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

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Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

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Manufacturing Date

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Category: Electrocardiograph, professional, multichannel

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

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Cleared under the same submission

K101403 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Welch Allyn, Inc.

Sources (1)

FDA UDI acbd7b37-e31a-402f-906e-3f9c1668b2ee 36 fields · synced May 30, 2026