Identity
- Trade Name
- Cleaning Solution with additive S8375 REF 944-126 FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- S8375 Cleaning Solution 175mL for ABL8XX FDA UDI
- Model / Reference
- 944-126 FDA UDI
- Description
- S8375 Cleaning Solution 175mL for ABL8XX FDA UDI
Identifiers
- Catalog Number
- 944-126 FDA UDI
- Primary DI / UDI-DI
- 05700699441263 FDA UDI
- FDA Product Code
- KHP FDA UDICGA FDA UDIJFP FDA UDICGL FDA UDIMQM FDA UDICGZ FDA UDICIG FDA UDICHL FDA UDIGHS FDA UDICEM FDA UDIKQI FDA UDIJGS FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1450 FDA UDI862.1345 FDA UDI862.1145 FDA UDI862.1225 FDA UDI862.1113 FDA UDI862.1170 FDA UDI862.1110 FDA UDI862.1120 FDA UDI864.7425 FDA UDI862.1600 FDA UDI864.7455 FDA UDI862.1665 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
No
FDA UDI
Category: Wash/cleaning solution IVD, automated/semi-automated system
Cleaning Solution with additive S8375 REF 944-126 by Radiometer Medical ApS — 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
- Radiometer Medical ApS
Sources (1)
- FDA UDI f98224c8-4caa-40a1-938e-910427e0f72a 36 fields · synced Jun 8, 2026