RadAR Vascular Compression Device 140-0160-00

GUDID 20815614020085

The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustements to permit patent blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patent hemostatsis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4160 is natural in color.

Semler Technologies, Inc.

Radial artery compression device

• Primary Device ID: 20815614020085
• NIH Device Record Key: 968b64fc-8a27-40a4-b7d8-3f1cdf1357d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadAR Vascular Compression Device
• Version Model Number: 4160
• Catalog Number: 140-0160-00
• 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	10815614020088 [Primary]
GS1	20815614020085 [Package]; Contains: 10815614020088; Package: Case [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142122

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-10-16
• Device Publish Date: 2016-09-24

On-Brand Devices [RadAR Vascular Compression Device]

• 20815614020085: The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your p
• 30815614020075: The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your p