Identity
- Trade Name
- CueSee® Hyperbaric X-High FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers. FDA UDI
- Model / Reference
- 164.002.004 FDA UDI
- Description
- CueSee® Hyperbaric is an assayed, quality control material for professional use in the verification of the precision and accuracy of the critically high pO2 value range of many blood gas analyzers. FDA UDI
Identifiers
- Catalog Number
- 164.002.004 FDA UDI
- Primary DI / UDI-DI
- 08718734961093 FDA UDI
- 510(k) Number
- K955340 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple blood gas analyte IVD, control
CueSee® Hyperbaric X-High 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 78e02d51-1e96-493b-a79d-d7a117cb66c2 35 fields · synced May 30, 2026