Duns Number:303639066
Device Description: MiniCollect® TUBE 1 ml K3E K3EDTA lavender cap, with cross cut, Spray-dried
Catalog Number
450474
Brand Name
MiniCollect
Version/Model Number
450474
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 29, 2022
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
K982999,K982999,K982999
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
4874665a-e978-44e9-a3b6-d92b2c8814a1
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
39120017578551
Quantity per Package
10
Contains DI Package
29120017578554
Package Discontinue Date
April 29, 2022
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 |