Identity
- Trade Name
- Rinse Solution S4980 REF 944-130 FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- S4980 Rinse Solution 600mL, for ABL800 FLEX FDA UDI
- Model / Reference
- 944-130 FDA UDI
- Description
- S4980 Rinse Solution 600mL, for ABL800 FLEX FDA UDI
Identifiers
- Catalog Number
- 944-130 FDA UDI
- Primary DI / UDI-DI
- 05700699441300 FDA UDI
- FDA Product Code
- JFP FDA UDICEM FDA UDICIG FDA UDICHL FDA UDIGHS FDA UDIKHP FDA UDICGZ FDA UDIKQI FDA UDIMQM FDA UDICGA FDA UDICGL FDA UDIJGS FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1600 FDA UDI862.1110 FDA UDI862.1120 FDA UDI864.7425 FDA UDI862.1450 FDA UDI862.1170 FDA UDI864.7455 FDA UDI862.1113 FDA UDI862.1345 FDA UDI862.1225 FDA UDI862.1665 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: Wash/cleaning solution IVD, automated/semi-automated system
Rinse Solution S4980 REF 944-130 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 94b98b93-1726-4b53-a97b-889d4c987741 36 fields · synced May 30, 2026