Identity
- Trade Name
- CONTROL LIQUID, OXICOM, BOX FDA UDI
- Generic Name
- Intracardiac oximeter FDA UDI
- Device Name
- Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range. Box contains 3 vials of high range, 3 vials of medium range and 3 vials of low range. FDA UDI
- Model / Reference
- CONTROL LIQUID, OXICOM, BOX FDA UDI
- Description
- Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range. Box contains 3 vials of high range, 3 vials of medium range and 3 vials of low range. FDA UDI
Identifiers
- Catalog Number
- 0034091.000 FDA UDI
- Primary DI / UDI-DI
- B154O00340910000 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Intracardiac oximeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intracardiac oximeter
Control Liquid, Oxicom, Box by Waters Medical Systems, 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
- Waters Medical Systems, LLC
Sources (1)
- FDA UDI da5b1a8f-0f8d-4e0f-bf79-946b9004cb74 36 fields · synced Jun 9, 2026