ExpressAR Belt Kit 160-2020-02

GUDID 10815614020651

The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Large SuperComfort Disc (2” dia.) for use with the ExpressAR device.

Semler Technologies, Inc.

Femoral artery compression system, manual, single-use

• Primary Device ID: 10815614020651
• NIH Device Record Key: 012210d7-3096-426a-ae80-ac475e4aab66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExpressAR Belt Kit
• Version Model Number: 160-2020-02
• Catalog Number: 160-2020-02
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020651 [Primary]
GS1	20815614020658 [Package]; Package: Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970027

FDA Product Code

• DXC: Clamp, Vascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2024-10-16
• Device Publish Date: 2016-09-24

On-Brand Devices [ExpressAR Belt Kit]

• 20815614020665: The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Jumbo SuperComfort Disc (2.625�
• 10815614020651: The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Large SuperComfort Disc (2” d