Identity
- Trade Name
- Oxicom 3000 Oximeter FDA UDI
- Generic Name
- Intracardiac oximeter FDA UDI
- Device Name
- Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2). FDA UDI
- Model / Reference
- Oxicom 3000 FDA UDI
- Description
- Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2). FDA UDI
Identifiers
- Catalog Number
- 0006790.000 FDA UDI
- Primary DI / UDI-DI
- B154O00067900000 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
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
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Serial Number
Yes
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Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oxicom 3000 Oximeter by Waters Medical Systems, LLC — Class II — 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Waters Medical Systems, LLC
Sources (1)
- FDA UDI 79213ab7-c89d-451a-999a-850274cf695c 36 fields · synced Jun 9, 2026