Duns Number:151639481
Device Description: Blood Specimen Convenience Kit
Catalog Number
SA95201
Brand Name
Blood Specimen Convenience Kit
Version/Model Number
SA95201
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)
-
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
d38d60ab-cc48-4387-92fa-ec074e5e8498
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
August 25, 2017
Package DI Number
10859952006144
Quantity per Package
48
Contains DI Package
00859952006147
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |