Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
79987B
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
PEZ
Product Code Name
Central venous catheter dressing change kit
Public Device Record Key
7ca3db35-9cd2-48b7-80a5-8a9ad9e8bb27
Public Version Date
December 29, 2021
Public Version Number
1
DI Record Publish Date
December 21, 2021
Package DI Number
20809160364182
Quantity per Package
20
Contains DI Package
10809160364185
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 |