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SEMLER TECHNOLOGIES, INC. 160-2027-00 ExpressAR Belt Kit

Company Name

SEMLER TECHNOLOGIES, INC.

Catalog Number

160-2027-00

Description

The ExpressAR Belt Kit provides a non-sterile Belt and a sterile Jumbo SuperComfort Disc (2.625” dia.) for use with the ExpressAR device.

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Summary

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First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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Additional Details

Device Identifier

10815614020668

Is RX

Yes

Is Over the Counter

No

Requires Sterilization

No

Is Sterile

No

Is Single Use

Yes

Categories

Barcode Mapping

Unit of Measurement	Eaches	GTIN
Each	1	10815614020668
Box of 15	15	20815614020665