Duns Number:117229530
Device Description: Blood Collection Device
Catalog Number
-
Brand Name
Maveric Medical
Version/Model Number
M6010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 30, 2099
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"
Yes
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
KST
Product Code Name
System, Blood Collection, Vacuum-Assisted, Manual
Public Device Record Key
4c9f0bfa-92e1-454c-9769-13171595fac7
Public Version Date
August 07, 2020
Public Version Number
1
DI Record Publish Date
July 30, 2020
Package DI Number
10860002576616
Quantity per Package
200
Contains DI Package
00860002576619
Package Discontinue Date
July 30, 2099
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 6 |