CompressAR StrongArm XL SuperComfort Stand 160-0001-14

GUDID 10815614020538

The CompressAR StrongArm XL SuperComfort Stand is an extended length stand with a base plate for use with a Hill-Rom TotalCare® bed and is used with CompressAR SuperComfort 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: 10815614020538
• NIH Device Record Key: bcc0b23e-f0ab-4db5-bcd8-e1c481e06947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompressAR StrongArm XL SuperComfort Stand
• Version Model Number: 1200
• Catalog Number: 160-0001-14
• 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	10815614020538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040615

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 [CompressAR StrongArm XL SuperComfort Stand]

• 10815614020569: The CompressAR StrongArm XL SuperComfort Stand is an extended length stand with a base plate for
• 10815614020538: The CompressAR StrongArm XL SuperComfort Stand is an extended length stand with a base plate for
• 10815614020507: The CompressAR StrongArm XL SuperComfort Stand is an extended length stand used with CompressAR