Duns Number:117229530
Device Description: Blood Collection Needle, Safety, 21G x 1.25" with Preattached Tube Holder
Catalog Number
-
Brand Name
Maveric Medical
Version/Model Number
M6421
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 29, 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
K172763,K172763,K172763
Product Code
JKA
Product Code Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Public Device Record Key
e65a9560-c593-4310-8154-43ad942f58b0
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
July 29, 2021
Package DI Number
10850028131142
Quantity per Package
25
Contains DI Package
00850028131145
Package Discontinue Date
July 29, 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 |