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: ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Standard Connectivity includes WLAN, LAN, and USB; AM15E patient cable; IEC 13 wire, 15-lead lead set with banana plugs and EU FDA UDI
Model / Reference: 901133 FDA UDI
Description: ELI380 12-Lead Multi-Channel Electrocardiograph - Capacitive color touchscreen 17 in. swivel display (ERGO) with 1280 x 1024 resolution, English keyboard, AC or lithium ion battery operation includes 1 starter pack paper (Smart Paper 8.27 in. x 11 in.), ECG clip adapters (set of 10) and tab electrodes (pouch of 100); current software; adult and pediatric interpretation; Standard Connectivity includes WLAN, LAN, and USB; AM15E patient cable; IEC 13 wire, 15-lead lead set with banana plugs and EU FDA UDI

Identifiers

Catalog Number: ELI380-DBX44 FDA UDI
Primary DI / UDI-DI: 00732094265255 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

FDA UDI

Over-the-Counter

Yes

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

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Expiration Date

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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 f96724c3-aab4-483d-ae0c-f2e9cac817ea 35 fields · synced May 30, 2026