Duns Number:092364462
Catalog Number
-
Brand Name
MEDICAL ACTION INDUSTRIES
Version/Model Number
81341
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2020
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
LRS
Product Code Name
I.V. start kit
Public Device Record Key
c78a85ce-60be-4893-aed9-819914c2b36d
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
October 08, 2020
Package DI Number
20809160293468
Quantity per Package
100
Contains DI Package
10809160293461
Package Discontinue Date
October 08, 2020
Package Status
Not 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 |