Duns Number:303639066
Device Description: MiniCollect® TUBE 1 ml 9NC Coagulation sodium citrate 3.8% blue cap, with cross cut
Catalog Number
450409
Brand Name
MiniCollect
Version/Model Number
450409
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 2021
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
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
9577872f-b47e-4708-a595-e116b80b127d
Public Version Date
May 13, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
39120017578421
Quantity per Package
10
Contains DI Package
29120017578424
Package Discontinue Date
May 12, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |