Duns Number:020275145
Device Description: Column, Desiccator, Disposable, 3.5 In
Catalog Number
153300
Brand Name
Column, Desiccator, Disposable, 3.5 In
Version/Model Number
Column, Desiccator, Disposable, 3.5 In - 153300
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
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
-
Product Code
BSF
Product Code Name
Absorber, Carbon-Dioxide
Public Device Record Key
b50d3128-4f8d-4d63-9b3a-fed10c9b02a7
Public Version Date
April 07, 2020
Public Version Number
1
DI Record Publish Date
March 30, 2020
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 | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |