Duns Number:042075700
Device Description: The CompressAR Oval (Elliptical) Comfort Disc is a sterile, single use product that is att The CompressAR Oval (Elliptical) Comfort Disc is a sterile, single use product that is attached to the CompressAR System Stand to apply compression to the femoral artery during hemostasis. The Model 5197 is an oval (ellliptical) disc with upturned edges (1.75” x 2.5").
Catalog Number
150-0197-06
Brand Name
CompressAR Elliptical Comfort Disc
Version/Model Number
5197
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K891000,K891000,K891000
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
c1cb5fa9-3c61-42d2-be38-53ce1551cbe1
Public Version Date
January 17, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020207
Quantity per Package
12
Contains DI Package
10815614020200
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |