Duns Number:444776777
Device Description: IV safety catheter
Catalog Number
-
Brand Name
Wolf-Pak Self Safe Safety IV Catheter
Version/Model Number
3728760
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"
Yes
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
-
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
6c32d736-5113-4447-b69f-f02dcd91e6ff
Public Version Date
January 28, 2020
Public Version Number
1
DI Record Publish Date
January 20, 2020
Package DI Number
58032248372875
Quantity per Package
4
Contains DI Package
38032248372871
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 105 |