Identity
- Trade Name
- Welch Allyn, Inc. FDA UDI
- Generic Name
- Ophthalmic/otologic diagnostic set FDA UDI
- Device Name
- Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, ABPM-6100S Ambulatory Blood Pressure System, PC-Based SpiroPerfect Spirometer FDA UDI
- Model / Reference
- 901047 FDA UDI
- Description
- Welch Allyn CardioPerfect Workstation with PC-Based 12-Lead Resting Electrocardiograph, Automatic ECG Interpretation, AHA ECG Cable, ABPM-6100S Ambulatory Blood Pressure System, PC-Based SpiroPerfect Spirometer FDA UDI
Identifiers
- Catalog Number
- 101455 FDA UDI
- Primary DI / UDI-DI
- 00732094070118 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Ophthalmic/otologic diagnostic set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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: Ophthalmic/otologic diagnostic set
Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic/otologic diagnostic set.
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- Diagnostix™ — American Diagnostic Corporation · Class I
- Adstation™ — American Diagnostic Corporation · 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 |
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Manufacturer
- Manufacturer
- Welch Allyn, Inc.
Sources (1)
- FDA UDI 1a012e62-ed18-4261-a587-4a02eac1dae4 35 fields · synced Jun 1, 2026