Identity
- Trade Name
- Change Healthcare Cardiology ECG Mobile FDA UDI
- Generic Name
- Cardiac mapping system computer FDA UDI
- Model / Reference
- 1.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540262120028 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiac mapping system computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
MR Unsafe FDA UDI
Change Healthcare Cardiology ECG Mobile by Change Healthcare Israel , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Israel , Ltd.
Sources (1)
- FDA UDI f6d8e978-9b7b-4576-bf24-fe2df30ec968 33 fields · synced May 31, 2026