Duns Number:117988954
Device Description: Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880
Catalog Number
-
Brand Name
Sodasorb® HMED, 4-8, W-V Indicating, Pail (17 kg), Smiths Medical 008880
Version/Model Number
CD02-0007
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBL
Product Code Name
Absorbent, Carbon-Dioxide
Public Device Record Key
1ccd78ea-b69b-4231-a4ba-0fc4a0e6f2dc
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
November 17, 2021
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 | 4 |