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PALL ORO gas line filter
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ORO1HModel BB25GS
Identity
- Trade Name
- PALL ORO gas line filter EUDAMEDPall® Oxygenator Gas Line Filter FDA UDI
- Generic Name
- Microbial medical gas filter, sterile, single-use FDA UDI
- Device Name
- Pall Ultipor 25 Breathing System Filter EUDAMEDBi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases. FDA UDI
- Model / Reference
- BB25GS EUDAMEDORO1H EUDAMEDFDA UDI
- Description
- Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases. FDA UDI
Identifiers
- Catalog Number
- ORO1H FDA UDI
- Primary DI / UDI-DI
- 05034480000446 EUDAMEDFDA UDI
- Basic UDI-DI
- 5034480GSLF05NINVFE EUDAMED
- FDA Product Code
- JQC FDA UDI
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
- GMDN Term
- Microbial medical gas filter, sterile, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Secretion suction kit
PALL ORO gas line filter by Pall International SARL — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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- Bioseal Inc. — BIOSEAL · Class I
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 | 5034480GSLF05NINVFE | 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 15b3e3fe-c9f7-4e96-868b-c0d800ad43f1 61 fields · synced Jun 20, 2026
- FDA UDI 9ed37a22-2a66-41dd-85ef-5fa11917fe1e 36 fields · synced May 30, 2026