Duns Number:080312381
Catalog Number
-
Brand Name
Kurin Blood Collection Set, 21 Ga, BD Vacutainer
Version/Model Number
D-11221
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 23, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
e3418003-cfd9-4c44-96a3-777612826121
Public Version Date
July 23, 2020
Public Version Number
5
DI Record Publish Date
March 13, 2017
Package DI Number
20851682007030
Quantity per Package
4
Contains DI Package
10851682007033
Package Discontinue Date
July 23, 2018
Package Status
Not 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. | 8 |