Duns Number:797372554
Device Description: Safety IV Catheter, Straight type (24Gx1")
Catalog Number
-
Brand Name
Nipro SafeTouch IV Catheter
Version/Model Number
NI-CSF2425PET
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
ceb551fe-5532-49ce-bb68-855537b99685
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 15, 2022
Package DI Number
10383790011157
Quantity per Package
50
Contains DI Package
00383790011150
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. | 230 |