CompressAR Universal Stand 160-0000-05

GUDID 10815614020460

The CompressAR Universal Stand is used with CompressAR Discs, to provide hemostasis of the femoral vascular access site following femoral artery catheterization procedures.

Semler Technologies, Inc.

Femoral artery compression system, manual, reusable

• Primary Device ID: 10815614020460
• NIH Device Record Key: 7445ec4e-abd4-4449-8944-ef4194571af5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR Universal Stand
• Version Model Number: 6000
• Catalog Number: 160-0000-05
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	10815614020460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925809

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

Devices Manufactured by Semler Technologies, Inc.

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• 10815614020026 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
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• 10815614020040 - ComfortPress Hand-Held Vascular Compression Assist Device: 2024-10-16 The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device.
• 10815614020064 - PressureMate Compression Assist Device: 2024-10-16 The PressureMate Compression Assist Device is designed to enhance comfort for the practitioner and the patient when applying ext
• 30815614020075 - RadAR Vascular Compression Device: 2024-10-16 The RadAR Vascular Compression Device Model 4150 provides economical, safe hemostasis for your post-catheterization radial acces
• 20815614020085 - RadAR Vascular Compression Device: 2024-10-16 The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial acces