Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
78894
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OWL
Product Code Name
Peripheral catheter insertion kit
Public Device Record Key
1d4953e1-2abe-475b-8f19-c1fed1ce7a7a
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
April 12, 2019
Package DI Number
20809160235703
Quantity per Package
20
Contains DI Package
10809160235706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 548 |
2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
U | Unclassified | 1 |