RadAR EasyClik Vascular Compression Device 140-0195-00

GUDID 20815614020849

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.

SEMLER TECHNOLOGIES, INC.

Radial artery compression device
Primary Device ID20815614020849
NIH Device Record Key31b9e8fd-015b-4186-957e-f390e52d4cac
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadAR EasyClik Vascular Compression Device
Version Model Number4195
Catalog Number140-0195-00
Company DUNS042075700
Company NameSEMLER TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110815614020842 [Primary]
GS120815614020849 [Package]
Contains: 10815614020842
Package: Box [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXCClamp, Vascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-08
Device Publish Date2020-04-30

On-Brand Devices [RadAR EasyClik Vascular Compression Device]

20815614020115The RadAR EasyClik Vascular Compression Device Model 4185 provides economical, safe hemostasis f
20815614020849The RadAR EasyClik Vascular Compression Device Model 4195 provides economical, safe hemostasis f
20815614020092The RadAR EasyClik Vascular Compression Device Model 4180 provides economical, safe hemostasis f

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