Duns Number:216344051
Device Description: Moisture responsive IV catheter dressing
Catalog Number
4649
Brand Name
IV3000 10X20CM CTN 50
Version/Model Number
4649
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
0cfceae9-427f-4541-b5c8-925c35b1b3dc
Public Version Date
July 08, 2020
Public Version Number
2
DI Record Publish Date
May 15, 2020
Package DI Number
05000223410810
Quantity per Package
50
Contains DI Package
05000223426668
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 63 |
2 | A medical device with a moderate to high risk that requires special controls. | 126 |
U | Unclassified | 1 |