Identity
- Trade Name
- Centricity FDA UDI
- Generic Name
- Patient health record information system FDA UDI
- Device Name
- MD CPN 6.97 MEDICAL DEVICE FDA UDI
- Model / Reference
- Perinatal6.97 FDA UDI
- Description
- MD CPN 6.97 MEDICAL DEVICE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682123785 FDA UDI
- 510(k) Number
- K111614 FDA UDI
- FDA Product Code
- HGM FDA UDIMSX FDA UDI
- GMDN Term
- Patient health record information system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 FDA UDI870.2300 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
Centricity by GE Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- GE Healthcare
Sources (1)
- FDA UDI 23b7727e-b3c2-4f76-b6ca-7b3b64c3282b 35 fields · synced May 30, 2026