Identity
- Trade Name
- OBIX Perinatal Data System FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance. FDA UDI
- Model / Reference
- 8.1 FDA UDI
- Description
- OBIX Perinatal Data System is used in perinatal areas of the hospital (L&D, PP, Antepartum, Triage). A patient record is populated with information related to perinatal fetal monitor surveillance. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868102000423 FDA UDI
- 510(k) Number
- K121208 FDA UDI
- FDA Product Code
- HGM FDA UDI
- GMDN Term
- Patient health record information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2740 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
Yes
FDA UDI
Category: Patient health record information system application software
OBIX Perinatal Data System by Clinical Computer Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Clinical Computer Systems, Inc.
Sources (1)
- FDA UDI 72c8025f-e49f-4c6e-a185-b50125af8818 34 fields · synced Jun 9, 2026