Duns Number:117229530
Device Description: Blood Collection Set, Safety, 21G x 3/4", 7" Tubing, Preattached Holder
Catalog Number
-
Brand Name
Maveric Medical
Version/Model Number
M6217
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2021
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
344c8ca6-efdd-4f25-bfc1-022516bf5567
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
July 29, 2021
Package DI Number
10085002813169
Quantity per Package
25
Contains DI Package
00085002813162
Package Discontinue Date
September 25, 2021
Package Status
Not 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 |