Duns Number:216344051
Device Description: Moisture responsive IV catheter dressing
Catalog Number
66024008 & 4008
Brand Name
IV3000-1-HAND 10X12CM-CARTON OF 50
Version/Model Number
66024008
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
a68c5c24-bcf0-4203-8460-6034d1cf8564
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
June 04, 2021
Package DI Number
00040565115634
Quantity per Package
50
Contains DI Package
05000223417406
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 |