Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Electrocardiograph, professional, multichannel FDA UDI
- Device Name
- Welch Allyn Diagnostic Cardiology Suite Resting ECG PC based 12-Lead Multi-Channel Resting ECG - software; AM12 wired acquisition module; IEC 10 wire, 12-lead lead set with banana plugs; DICOM FDA UDI
- Model / Reference
- 901128 FDA UDI
- Description
- Welch Allyn Diagnostic Cardiology Suite Resting ECG PC based 12-Lead Multi-Channel Resting ECG - software; AM12 wired acquisition module; IEC 10 wire, 12-lead lead set with banana plugs; DICOM FDA UDI
Identifiers
- Catalog Number
- CC-RXX-AIDA FDA UDI
- Primary DI / UDI-DI
- 00732094324051 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
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
Similar devices
Also classified as Electrocardiograph, professional, multichannel.
- ers2 1CH ECG Adapter US Set 5 pcs. — ergoline GmbH · Class II
- Premier Heart MCG Model VH12 — PREMIER HEART, LLC · Class II
- ELI 380 — MORTARA INSTRUMENT, INC. · Class II
- Norav 1200 Series PC-ECG — Norav Medical Inc. · Class II
- ELI 280 — MORTARA INSTRUMENT, INC. · Class II
- ELI 280 — MORTARA INSTRUMENT, INC. · Class II
- Venni / Biolight — VENNI INSTRUMENTS INC. · Class II
- ELI 150c — MORTARA INSTRUMENT, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 2585dc2c-0466-45f5-9761-891cd4c80d68 35 fields · synced May 30, 2026