Duns Number:058027475
Device Description: Administration Set with 60 drop Vented Chamber, Needlefree Y-site, Stopcocks & Extension S Administration Set with 60 drop Vented Chamber, Needlefree Y-site, Stopcocks & Extension Set
Catalog Number
-
Brand Name
Codan
Version/Model Number
C487-W
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
e4806bd9-cf38-40da-9afd-0b29fb43e92f
Public Version Date
November 08, 2021
Public Version Number
1
DI Record Publish Date
October 31, 2021
Package DI Number
00813153026984
Quantity per Package
1
Contains DI Package
10813153026981
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 381 |