ClampEase Vascular Compression Device 160-2010-00

GUDID 10815614020620

The ClampEase mechanical compression device provides a hands-free approach for hemostasis following femoral artery catheterization procedures. The ClampEase Stystem is comprised of a durable ClampEase Stand and a sterile, disposable ball or taper style Disc. The Model C-700 ClampEase System is compatible with those styles of Discs that are designed for Ball Tip Attachment.

Semler Technologies, Inc.

Femoral artery compression system, manual, reusable

• Primary Device ID: 10815614020620
• NIH Device Record Key: 10ad1cab-8f18-4c09-96aa-f946cab91283
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClampEase Vascular Compression Device
• Version Model Number: C-700
• Catalog Number: 160-2010-00
• 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: 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	10815614020620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964662

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

On-Brand Devices [ClampEase Vascular Compression Device]

• 10815614020637: The ClampEase mechanical compression device provides a hands-free approach for hemostasis follow
• 10815614020620: The ClampEase mechanical compression device provides a hands-free approach for hemostasis follow