Duns Number:002054419
Device Description: Bi-directional bacterial/viral removal filter. Indicated for use on ventilators, water bat 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.
Catalog Number
BB50T
Brand Name
Pall® Breathing Circuit Filter
Version/Model Number
BB50T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K791307,K791307
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
22f34cd0-f5ab-41e2-8c73-bf1bb8f355b0
Public Version Date
September 22, 2020
Public Version Number
6
DI Record Publish Date
June 01, 2016
Package DI Number
30363207000244
Quantity per Package
50
Contains DI Package
00636207000248
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |