Identity
- Trade Name
- CueSee® Hypoxic FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2). FDA UDI
- Model / Reference
- CueSee® Hypoxic X-Low FDA UDI
- Description
- CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2). FDA UDI
Identifiers
- Catalog Number
- 166.001.005 FDA UDI
- Primary DI / UDI-DI
- 08718734960652 FDA UDI
- 510(k) Number
- K152553 FDA UDI
- FDA Product Code
- JJS FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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: Multiple blood gas analyte IVD, control
CueSee® Hypoxic by Eurotrol B.V. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Eurotrol B.V.
Sources (1)
- FDA UDI 900ddfd9-46bd-4857-9b0e-2777943e68d9 35 fields · synced Jun 8, 2026