Identity
- Trade Name
- McKesson Cardiology FDA UDI
- Generic Name
- Cardiology information system FDA UDI
- Model / Reference
- 14.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 80010939070025 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Cardiology information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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: Cardiology information system
McKesson Cardiology by Change Healthcare Canada Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiology information system.
- Change Healthcare Cardiology — Change Healthcare Israel , Ltd. · Class II
- Change Healthcare Cardiology — Change Healthcare Israel , Ltd. · Class II
- Change Healthcare Cardiology — Change Healthcare Canada Company · Class II
- Change Healthcare Cardiology — Change Healthcare Canada Company · Class II
- McKesson Cardiology™ — Change Healthcare Canada Company · Class II
- Change Healthcare Cardiology — Change Healthcare Canada Company · Class II
- Change Healthcare Cardiology — Change Healthcare Canada Company · Class II
- Change Healthcare Cardiology — Change Healthcare Canada Company · 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
- Change Healthcare Canada Company
Sources (1)
- FDA UDI 421c7b6d-323a-4b96-9c6b-1be1aec360b8 32 fields · synced Jun 1, 2026