Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0 FDA UDI
- Model / Reference
- 901012 FDA UDI
- Description
- SOFTWARE MONITIOR WAVEFORM VIEWER V2.1.0 FDA UDI
Identifiers
- Catalog Number
- 11093-003-50 FDA UDI
- Primary DI / UDI-DI
- 00732094296341 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiology information system application software
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiology information system application software.
- EZLink-C — SCOTTCARE CORPORATION, THE · Class II
- CardioConfirm — MORTARA INSTRUMENT, INC. · Class II
- SENTINEL — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Pathfinder SL — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- EZLink — SCOTTCARE CORPORATION, THE · Class II
- Cordiana Dx16 — Cordiana Medical Informatics AG · Class II
- Epicardia 5000 — MEDICOMP, INC. · Class II
- Lifescreen Pro — SPACELABS HEALTHCARE (WASHINGTON), 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 6535aa03-dcf1-4806-bb5e-d3d2a62ecba6 35 fields · synced Jun 6, 2026