Identity
- Trade Name
- ABL90 FLEX SP90 FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- Solution pack XL for ABL90 FLEX and ABL90 FLEX PLUS FDA UDI
- Model / Reference
- 944-457 FDA UDI
- Description
- Solution pack XL for ABL90 FLEX and ABL90 FLEX PLUS FDA UDI
Identifiers
- Catalog Number
- 944-457 FDA UDI
- Primary DI / UDI-DI
- 05700699444578 FDA UDI
- FDA Product Code
- CHL FDA UDIJFP FDA UDIGKR FDA UDIMQM FDA UDIJIX FDA UDIJGS FDA UDIJJY FDA UDIGHS FDA UDICGA FDA UDIKHP FDA UDICEM FDA UDICGZ FDA UDIKQI FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI862.1145 FDA UDI864.5620 FDA UDI862.1113 FDA UDI862.1150 FDA UDI862.1665 FDA UDI862.1660 FDA UDI864.7425 FDA UDI862.1345 FDA UDI862.1450 FDA UDI862.1600 FDA UDI862.1170 FDA UDI864.7455 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Abl90 Flex Sp90 by Radiometer Medical ApS — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Radiometer Medical ApS
Sources (1)
- FDA UDI d9b86ec3-57d3-4616-baa3-b7dbb105eeb2 36 fields · synced May 30, 2026