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: ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1" display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - Letter, 8.5" x 11"); current software ; Brazil 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); Ethernet LAN + WLAN (WPA2) + USBD; Expanded storage (up to 200 ECGs); FDA UDI
Model / Reference: 901132 FDA UDI
Description: ELI280 12-Lead Multi-Channel Electrocardiograph - Resistive color touchscreen 10.1" display, AC or battery operation with WAM Wireless Acquisition Module (includes 1 starter pack paper - Letter, 8.5" x 11"); current software ; Brazil 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); Ethernet LAN + WLAN (WPA2) + USBD; Expanded storage (up to 200 ECGs); FDA UDI

Identifiers

Catalog Number: ELI280-CEA-AAFBX FDA UDI
Primary DI / UDI-DI: 00732094354379 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

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

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 d71cd1c0-07ea-4173-a512-a7814255de61 35 fields · synced Jun 1, 2026