Identity
- Trade Name
- S53516 10mL REF 943-905 Electrode Cleaner FDA UDI
- Generic Name
- Domestic refuse/waste disposal assistive device FDA UDI
- Device Name
- Electrode Cleaner (pH, pO2, pCO2) for BPH5, ABL5/50/5XX S53516 FDA UDI
- Model / Reference
- 943-905 FDA UDI
- Description
- Electrode Cleaner (pH, pO2, pCO2) for BPH5, ABL5/50/5XX S53516 FDA UDI
Identifiers
- Catalog Number
- 943-905 FDA UDI
- Primary DI / UDI-DI
- 05700699439055 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Domestic refuse/waste disposal assistive device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI
- Commercial Distribution
- Not 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
S53516 10mL REF 943-905 Electrode Cleaner by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 4ebb2562-cf53-4eeb-83ba-377639f1a97b 37 fields · synced May 30, 2026