Duns Number:809699023
Device Description: PROTECTION STATION PLUS
Catalog Number
-
Brand Name
NAMIC
Version/Model Number
64000945
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K852140,K852140
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
64a6199d-deb2-497c-a28c-b212a782a4eb
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
H965640009451
Quantity per Package
20
Contains DI Package
H965640009450
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 71 |
2 | A medical device with a moderate to high risk that requires special controls. | 1641 |