Duns Number:303639066
Device Description: MiniCollect® Complete 0.25 / 0.5 ml K2E K2EDTA lavender cap, pre-assembled with Carrier Tu MiniCollect® Complete 0.25 / 0.5 ml K2E K2EDTA lavender cap, pre-assembled with Carrier Tube 13x75
Catalog Number
450547
Brand Name
MiniCollect
Version/Model Number
450547
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182078,K182078,K182078,K182078
Product Code
JKA
Product Code Name
Tubes, vials, systems, serum separators, blood collection
Public Device Record Key
92c7283d-0d4f-40cb-8261-a0effe31af1b
Public Version Date
November 10, 2021
Public Version Number
2
DI Record Publish Date
February 27, 2019
Package DI Number
49120049206030
Quantity per Package
4
Contains DI Package
39120049206033
Package Discontinue Date
-
Package Status
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 |