Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
74466C
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
LRS
Product Code Name
I.V. start kit
Public Device Record Key
5d5abc9f-5403-40a5-b6a4-409d640209e7
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 21, 2020
Package DI Number
20809160341619
Quantity per Package
100
Contains DI Package
10809160341612
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 |