Duns Number:092364462
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
79831B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2022
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OFM
Product Code Name
Phlebotomy blood collection kit
Public Device Record Key
df1127ea-f9d2-4dba-b45d-357dcedbbd1a
Public Version Date
February 07, 2022
Public Version Number
3
DI Record Publish Date
December 02, 2020
Package DI Number
20809160296360
Quantity per Package
20
Contains DI Package
10809160296363
Package Discontinue Date
February 04, 2022
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 |