Duns Number:785952607
Device Description: IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/V
Catalog Number
-
Brand Name
IS CAN: 1KG SODA LIME ABSORBER - SPHERASORB W/V
Version/Model Number
2196000
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
22af6f29-94b6-4533-ba0b-27af4332701b
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 28, 2021
Package DI Number
05030267090358
Quantity per Package
6
Contains DI Package
05030267090341
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |