Duns Number:002054419
Device Description: Conserve Small Volume HME with Monitoring Port. For use with mechanically ventilated patie Conserve Small Volume HME with Monitoring Port. For use with mechanically ventilated patientsto retain heat and humidity while removing bacterial/viral contaminants with an efficiency of99.999%.
Catalog Number
BB25A
Brand Name
Pall Conserve™ Small Volume HME
Version/Model Number
BB25A
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
0654eb28-0b1f-4619-afd0-879173b97796
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
June 01, 2016
Package DI Number
30636207000232
Quantity per Package
50
Contains DI Package
00636207000231
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 |