Duns Number:488052341
Device Description: Sepax Kit Accessories
Catalog Number
10022
Brand Name
DMSO Extension Line
Version/Model Number
FA-100.1
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
OAO
Product Code Name
Cord Blood Processing System And Storage Container
Public Device Record Key
4ba691fc-15ec-4c4d-89f8-082cf9b347ef
Public Version Date
March 09, 2022
Public Version Number
3
DI Record Publish Date
January 13, 2017
Package DI Number
07640125650334
Quantity per Package
24
Contains DI Package
07640125650327
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 24 |