CompressAR Compass Hand-Held Vascular Compression Assist Device

Basic Information

• Brand Name: CompressAR Compass Hand-Held Vascular Compression Assist Device
• Primary DI: 10815614020002
• Version / Model: 3000
• Catalog Number: 130-0000-01
• Company Name: SEMLER TECHNOLOGIES, INC.
• Labeler DUNS: 042075700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 77106e9c-fb6e-4b9a-955b-a9add6481420

Device Description

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46367	Femoral artery compression system, manual, reusable	A noninvasive, non-powered device intended to provide compression for haemostasis to the puncture site on a patient having undergone femoral artery catheterization, typically as an alternative to direct hand pressure. The compressing portion could be one of a variety of designs (e.g., disc affixed to a handle, ball, dome or roller, manually-inflatable bulb) and is typically held in place with a frame, bandage, or straps secured around the patient's hips/thigh. It is typically used following coronary angiography/ventriculography and PTCA; it may in addition be used on brachial and radial arteries or after venipuncture. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10815614020002	GS1

Premarket Submissions

Submission Number	Supplement Number
K053398	000