Duns Number:079299318
Device Description: VerifyNow System (Demonstration)
Catalog Number
86003D
Brand Name
VerifyNow System
Version/Model Number
86003D
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
K992531
Product Code
JOZ
Product Code Name
System, Automated Platelet Aggregation
Public Device Record Key
7debd393-e9c7-48c3-8926-4f841aa22588
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
January 25, 2017
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 43 |