CompressAR Compass Hand-Held Vascular Compression Assist Device 130-0000-01

GUDID 10815614020002

The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using Compass in much the same way that they would when applying manual pressure. The CompressAR Compass Hand-Held Compression Assist Device is comprised of a non-sterile handle for use with disposable, sterile SuperComfort compression discs (Model 5303 or 5305).

Semler Technologies, Inc.

Femoral artery compression system, manual, reusable

• Primary Device ID: 10815614020002
• NIH Device Record Key: 77106e9c-fb6e-4b9a-955b-a9add6481420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Compass Hand-Held Vascular Compression Assist Device
• Version Model Number: 3000
• Catalog Number: 130-0000-01
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	10815614020002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053398

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: 6
• Public Version Date: 2024-10-16
• Device Publish Date: 2016-09-24

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