Duns Number:042075700
Device Description: The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compres The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using Compass in much the same way that they would when applying manual pressure. The CompressAR Compass Hand-Held Compression Assist Device is comprised of a non-sterile handle for use with disposable, sterile SuperComfort compression discs (Model 5303 or 5305).
Catalog Number
130-0000-01
Brand Name
CompressAR Compass Hand-Held Vascular Compression Assist Device
Version/Model Number
3000
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
-
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
K053398
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
77106e9c-fb6e-4b9a-955b-a9add6481420
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 |