Duns Number:303639066
Device Description: MiniCollect® Carrier Tube amber, for bilirubin, 13x75
Catalog Number
450419
Brand Name
MiniCollect
Version/Model Number
450419
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
-
Product Code
FMH
Product Code Name
CONTAINER, SPECIMEN, STERILE
Public Device Record Key
39b5633b-4b83-487a-b8b5-1b96971f2727
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
39120017578469
Quantity per Package
10
Contains DI Package
29120017578462
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 |