Duns Number:002054419
Device Description: Ultipor 100 Breathing System Filter with Monitoring Port and Flex Tube. High efficiency ba Ultipor 100 Breathing System Filter with Monitoring Port and Flex Tube. High efficiency bacterial/viral filter and HME for patient end use with mechanical ventilation and circle anesthesia.
Catalog Number
BB100APF
Brand Name
Pall Ultipor™ 100 Breathing System Filter
Version/Model Number
BB100APF
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
f12d8bd4-5b43-4e5b-8045-b0394003a1b4
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
June 01, 2016
Package DI Number
30636207300691
Quantity per Package
50
Contains DI Package
00636207300690
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 |