Duns Number:052845583
Device Description: Whole Blood Hematology Control
Catalog Number
5300000278
Brand Name
MINOTROL 16
Version/Model Number
6x2.5mL
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
JPK
Product Code Name
Mixture, Hematology Quality Control
Public Device Record Key
20106d24-a2e8-4190-bb1b-447fcb8161df
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 14 |