Identity
- Trade Name
- Oxicom 2100 Box Kit FDA UDI
- Generic Name
- Intracardiac oximeter FDA UDI
- Device Name
- Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks FDA UDI
- Model / Reference
- Oxicom 2100 Kit FDA UDI
- Description
- Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks FDA UDI
Identifiers
- Catalog Number
- 0007290.000 FDA UDI
- Primary DI / UDI-DI
- B154OXIKIT21003 FDA UDI
- 510(k) Number
- K921519 FDA UDI
- GMDN Term
- Intracardiac oximeter FDA UDI
Classification
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oxicom 2100 Box Kit by Waters Medical Systems, LLC — 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Waters Medical Systems, LLC
Sources (1)
- FDA UDI 85088fc4-8f09-4a4b-919e-ce6a46768114 37 fields · synced Jun 9, 2026