CompressAR StrongArm XL 3-FingerJack Stand 160-0004-01

GUDID 10815614020552

The CompressAR StrongArm XL 3-FingerJack Stand is an extended length stand with a base plate for use with a Hill-Rom VersaCare® bed and is used with a CompressAR 3-FingerJack Disc, 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: 10815614020552
• NIH Device Record Key: 81abd2ba-4385-4bfc-9459-0afcf2734d50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR StrongArm XL 3-FingerJack Stand
• Version Model Number: 1400
• Catalog Number: 160-0004-01
• 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: 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	10815614020552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002767

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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