Identity
- Trade Name
- Pall® Breathing Circuit Filter FDA UDI
- Generic Name
- Microbial medical gas filter, reusable FDA UDI
- Device Name
- Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, water bath humidifiers and other medical gas equipment where the gas outlet fitting complies to ISO 5356-1 for the protection of the patient, staff, equipment and environment. Provides greater than 99.999% bacterial and viral efficiency. FDA UDI
- Model / Reference
- BB50T FDA UDI
- Description
- Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, water bath humidifiers and other medical gas equipment where the gas outlet fitting complies to ISO 5356-1 for the protection of the patient, staff, equipment and environment. Provides greater than 99.999% bacterial and viral efficiency. FDA UDI
Identifiers
- Catalog Number
- BB50T FDA UDI
- Primary DI / UDI-DI
- 00636207000248 FDA UDI
- 510(k) Number
- K791307 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Microbial medical gas filter, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 90 Milliliter FDA UDI
Category: Microbial medical gas filter, reusable
Pall® Breathing Circuit Filter by Global Life Sciences Solutions USA LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K791307 also covers:
- Pall Conserve™ Small Volume HME — Global Life Sciences Solutions USA LLC
- Pall Ultipor™ 100 Breathing System Filter — Global Life Sciences Solutions USA LLC
- Pall Ultipor™ 100 Breathing System Filter — Global Life Sciences Solutions USA LLC
- Pall Ultipor™ 100 Breathing System Filter — Global Life Sciences Solutions USA LLC
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
- Global Life Sciences Solutions USA LLC
Sources (1)
- FDA UDI 22f34cd0-f5ab-41e2-8c73-bf1bb8f355b0 37 fields · synced May 30, 2026