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 ID: 20815614020849
• NIH Device Record Key: 31b9e8fd-015b-4186-957e-f390e52d4cac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadAR EasyClik Vascular Compression Device
• Version Model Number: 4195
• Catalog Number: 140-0195-00
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020842 [Primary]
GS1	20815614020849 [Package]; Contains: 10815614020842; Package: Box [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092503

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [RadAR EasyClik Vascular Compression Device]

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