Identity
- Trade Name
- Membrane for E909 electrode FDA UDI
- Generic Name
- Blood gas pO2 IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX FDA UDI
- Model / Reference
- 942-042 FDA UDI
- Description
- D999 Membrane box for E909 pO2 electrode for ABL5/50/5XX FDA UDI
Identifiers
- Catalog Number
- 942-042 FDA UDI
- Primary DI / UDI-DI
- 05700699420428 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Blood gas pO2 IVD, kit, ion-selective electrode (ISE) 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
Membrane for E909 electrode 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 2036c073-1a48-42b6-acdd-13cfacdaa53b 37 fields · synced Jun 1, 2026