Identity
- Trade Name
- CUVETTES DC-80 Box 100 cuvettes FDA UDI
- Generic Name
- Intracardiac oximeter FDA UDI
- Device Name
- Disposable cuvettes for use with the Oxicom oximeter. FDA UDI
- Model / Reference
- CUVETTE DC-80 FDA UDI
- Description
- Disposable cuvettes for use with the Oxicom oximeter. FDA UDI
Identifiers
- Catalog Number
- 0010391.000 FDA UDI
- Primary DI / UDI-DI
- B154O0010391CUVEACH00 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
Yes
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
No
FDA UDI
Category: Intracardiac oximeter
CUVETTES DC-80 Box 100 cuvettes by Waters Medical Systems, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intracardiac oximeter.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- CONTROL LIQUID, OXICOM - Low vial — Waters Medical Systems, LLC · Class II
- CONTROL LIQUID, OXICOM, BOX — Waters Medical Systems, LLC · Class II
- CONTROL LIQUID, OXICOM - High vial — Waters Medical Systems, LLC · Class II
- CUVETTES DC-80 Box 100 cuvettes & 100 plugs — Waters Medical Systems, LLC · Class II
- CUVETTES DC-80 Box 100 cuvettes - Plugs — Waters Medical Systems, LLC · Class II
- CONTROL LIQUID, OXICOM - Medium vial — Waters Medical Systems, LLC · Class II
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 a4152b02-6e0f-4435-85ea-dcb7dac92b28 35 fields · synced Jun 9, 2026