Duns Number:312293991
Device Description: This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Catalog Number
-
Brand Name
Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set
Version/Model Number
2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
BK140211
Product Code
PMQ
Product Code Name
Peripheral Blood Processing Device For Wound Management
Public Device Record Key
adf8bbd9-e21f-404b-9e77-d7c677fe4e60
Public Version Date
November 12, 2021
Public Version Number
4
DI Record Publish Date
May 23, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |