Identity
- Trade Name
- PALL Supor AEF Filter EUDAMEDPall Supor® AEF Filter FDA UDI
- Generic Name
- Intravenous line filter FDA UDI
- Device Name
- Pall Supor AEF Filter EUDAMED0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing. FDA UDI
- Model / Reference
- AEF1E EUDAMEDAEF1NTE EUDAMEDFDA UDI
- Description
- 0.2 micron air eliminating filter with low protein binding Supor membrane for up to 24 hours use. Without attached extension tubing. FDA UDI
Identifiers
- Catalog Number
- AEF1NTE FDA UDI
- Primary DI / UDI-DI
- 05034480308825 EUDAMEDFDA UDI
- Basic UDI-DI
- 5034480IVFC05NINVE8 EUDAMED
- 510(k) Number
- K993379 FDA UDI
- FDA Product Code
- FPB FDA UDI
- EMDN Code
- A04010101 WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS) EUDAMED
- GMDN Term
- Intravenous line filter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Pore Size — 0.2 Micrometer FDA UDI
PALL Supor AEF Filter by Pall International SARL — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5034480IVFC05NINVE8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Pall International SARL
- EUDAMED SRN
- CH-MF-000023177
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 29f69ad7-c08b-46ac-8eee-cbe9c5063ba7 61 fields · synced Jun 19, 2026
- FDA UDI 704c48d9-d97c-42bb-9dc8-f73a42aab5e1 37 fields · synced May 30, 2026