Duns Number:042075700
Device Description: The RadAR EasyClik Vascular Compression Device Model 4195 provides economical, safe hemost The RadAR EasyClik Vascular Compression Device Model 4195 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustments to permit patient blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patient hemostasis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4195 is natural in color.
Catalog Number
140-0195-00
Brand Name
RadAR EasyClik Vascular Compression Device
Version/Model Number
4195
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
K092503,K092503
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
31b9e8fd-015b-4186-957e-f390e52d4cac
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
Package DI Number
20815614020849
Quantity per Package
25
Contains DI Package
10815614020842
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 |