Duns Number:303639066
Device Description: MiniCollect® Capillary for Heparin, 80 µL
Catalog Number
450436
Brand Name
MiniCollect
Version/Model Number
450436
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
GIO
Product Code Name
TUBE, COLLECTION, CAPILLARY BLOOD
Public Device Record Key
eb93e0f0-44a7-473a-a45c-c10245021807
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2020
Package DI Number
49120017578718
Quantity per Package
10
Contains DI Package
39120017578711
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 |