Identity
- Trade Name
- McKesson Cardiology Hemo FDA UDI
- Generic Name
- Cardiac catheterization laboratory computer FDA UDI
- Model / Reference
- 14.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 80010939050027 FDA UDI
- 510(k) Number
- K131497 FDA UDI
- FDA Product Code
- MWI FDA UDIDQK FDA UDI
- GMDN Term
- Cardiac catheterization laboratory computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI870.1425 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
No
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
No
FDA UDI
Category: Cardiac catheterization laboratory computer
McKesson Cardiology Hemo by Change Healthcare Canada Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac catheterization laboratory computer.
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- RXi® Cable — ACIST Medical Systems, Inc. · Class II
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- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
- OptoMonitor 3 — Opsens · Class II
- RXi® Cable — ACIST Medical Systems, Inc. · Class II
Cleared under the same submission
K131497 also covers:
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Canada Company
- Change Healthcare Cardiology Hemo — Change Healthcare Israel , Ltd.
- Change Healthcare Cardiology Hemo — Change Healthcare Israel , Ltd.
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
- Change Healthcare Canada Company
Sources (1)
- FDA UDI d88c0191-eb73-4217-b02a-e3315903158b 33 fields · synced May 30, 2026