Identity
- Trade Name
- Pall Oxygenator Gas Line Filter FDA UDI
- Generic Name
- Microbial medical gas filter, single-use FDA UDI
- Device Name
- 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
- Model / Reference
- ORO1HA FDA 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
- Primary DI / UDI-DI
- 15034480315882 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Microbial medical gas filter, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Category: Microbial medical gas filter, single-use
Pall Oxygenator Gas Line Filter by Global Life Sciences Solutions USA LLC — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Global Life Sciences Solutions USA LLC
Sources (1)
- FDA UDI 6f72a34b-bafe-4710-a54b-068f32b23385 33 fields · synced May 30, 2026