Duns Number:117988954
Device Description: Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak , Smiths Medical 008860
Catalog Number
-
Brand Name
Sodasorb® HMED, 4-8, W-V Indicating, Individual Canister Pak, Smiths Medical 008
Version/Model Number
CD02-0006
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
13f347f4-db8b-45a7-a1ce-a103a96d0341
Public Version Date
November 30, 2021
Public Version Number
2
DI Record Publish Date
November 17, 2021
Package DI Number
10850017239194
Quantity per Package
12
Contains DI Package
00850017239197
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |