Duns Number:129501685
Catalog Number
-
Brand Name
NA
Version/Model Number
ABS ABSORBENT CANISTER REUSABLE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
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
-
Product Code
BSF
Product Code Name
ABSORBER, CARBON-DIOXIDE
Public Device Record Key
fc14a408-36bb-46bb-905d-fc0c2a406a16
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 18, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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. | 73 |
3 | A medical device with high risk that requires premarket approval | 1 |