Duns Number:042075700
Device Description: The CompressAR StrongArm SuperComfort Stand is used with CompressAR SuperComfort Discs, to The CompressAR StrongArm SuperComfort Stand is used with CompressAR SuperComfort Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures.
Catalog Number
160-0000-16
Brand Name
CompressAR StrongArm SuperComfort Stand
Version/Model Number
6000
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"
-
For Single-Use
-
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
K040615
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
5faefe93-7667-4f7d-88b3-31d3e7ebd434
Public Version Date
October 05, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |