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: ELI150c 12-Lead Multi-Channel Electrocardiograph - Rx, Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module (includes 1 starter pack paper - Z-fold, 4.25" x 5.5"); software V1.3.1; US/Canada power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and Pediatric Interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); GSM/GPRS (US) and LAN; Standard storage (up to 40 ECGs); Multi-study support (Rx Only) FDA UDI
Model / Reference: 901129 FDA UDI
Description: ELI150c 12-Lead Multi-Channel Electrocardiograph - Rx, Color LCD display, AC or battery operation, with AM12 Wired Acquisition Module (includes 1 starter pack paper - Z-fold, 4.25" x 5.5"); software V1.3.1; US/Canada power cord; AHA 10 wire, 12-lead lead set with banana plugs; Adult and Pediatric Interpretation; ECG clip adapters (set of 10) and tab electrodes (pouch of 100); GSM/GPRS (US) and LAN; Standard storage (up to 40 ECGs); Multi-study support (Rx Only) FDA UDI

Identifiers

Catalog Number: ELI150C-JAA-AAIAB FDA UDI
Primary DI / UDI-DI: 00732094326734 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

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

FDA UDI

Manufacturing Date

FDA UDI

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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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 26112075-84ea-4b65-a893-16e3a6c06efa 35 fields · synced Jun 6, 2026