Duns Number:792740578
Device Description: QUICK-DRAW HEPARIN ADAPTER FOR USE WITH INNOVAC
Catalog Number
-
Brand Name
QUICK-DRAW HEPARIN ADAPTER
Version/Model Number
15-980
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K972969,K972969,K972969
Product Code
GIO
Product Code Name
Tube, Collection, Capillary Blood
Public Device Record Key
669b14f2-677b-4142-b962-5d336f1b1bb0
Public Version Date
August 09, 2018
Public Version Number
4
DI Record Publish Date
August 05, 2016
Package DI Number
50857182006093
Quantity per Package
5
Contains DI Package
30857182006099
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |