Identity
- Trade Name
- CueSee® BGEM FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, glucose, lactate, urea and creatinine measurements on blood gas, electrolytes and metabolite analyzers. For laboratory and near-patient (point-of-care) testing by healthcare professionals. CueSee® BGEM 1|2|3|4|5 contains: 1x CueSee® BGEM 1 (DI: 08718734962946) 1x CueSee® BGEM 2 (DI: 08718734962953) 1x CueSee® BGEM 3 (DI: 08718734962960) 1x CueSee® BGEM 4 (DI: 08718734962977) 1x CueSee® BGEM 5 (DI: 08718734962984) FDA UDI
- Model / Reference
- 1|2|3|4|5 FDA UDI
- Description
- CueSee® BGEM is an unassayed quality control material intended to verify the precision of pH, pCO2, pO2, Na+, K+, Ca2+, Cl-, glucose, lactate, urea and creatinine measurements on blood gas, electrolytes and metabolite analyzers. For laboratory and near-patient (point-of-care) testing by healthcare professionals. CueSee® BGEM 1|2|3|4|5 contains: 1x CueSee® BGEM 1 (DI: 08718734962946) 1x CueSee® BGEM 2 (DI: 08718734962953) 1x CueSee® BGEM 3 (DI: 08718734962960) 1x CueSee® BGEM 4 (DI: 08718734962977) 1x CueSee® BGEM 5 (DI: 08718734962984) FDA UDI
Identifiers
- Catalog Number
- 345.000.005 FDA UDI
- Primary DI / UDI-DI
- 08718734963028 FDA UDI
- FDA Product Code
- OHQ FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte 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
No
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
Yes
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/haemoximetry/electrolyte analyte IVD, control
CueSee® BGEM 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 a585fd83-affc-416c-93cf-6413c1e79cd5 34 fields · synced May 30, 2026