Duns Number:200152713
Catalog Number
-
Brand Name
QuikCoag Calcium Chloride 0.02M
Version/Model Number
4 mL
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)
-
FDA Premarket Submission
K022021,K022021
Product Code
GFO
Product Code Name
Activated Partial Thromboplastin
Public Device Record Key
cf39613f-32fc-49ba-87be-a9fde53015f9
Public Version Date
February 24, 2020
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
10627944000094
Quantity per Package
10
Contains DI Package
00627944000097
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |