Identity
- Trade Name
- Premier Heart MCG FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Device Name
- Premier Heart MCG Field Unit, Model CF19 FDA UDI
- Model / Reference
- CF19 FDA UDI
- Description
- Premier Heart MCG Field Unit, Model CF19 FDA UDI
Identifiers
- Catalog Number
- CF19 FDA UDI
- Primary DI / UDI-DI
- B320CF190 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1425 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
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
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiograph, professional, multichannelCardiopulmonary physiological parameter analysis software
Premier Heart MCG by Premier Heart, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Premier Heart, Llc
Sources (1)
- FDA UDI 2e924422-a9b5-41fa-9f4a-50c9d9331b6e 35 fields · synced May 30, 2026