What is FDA product code LIX?

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software

Cardiovascular › TherapeuticAid, Cardiopulmonary Resuscitation

CPRmeter 2 (Multi-Bundle)

Name: CPRmeter 2 (Multi-bundle)
Brand: CPRmeter 2 (Multi-bundle)

The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provide real-time feedback on manual chest compression (i.e depth of compression) performed during…

Registry build 21.09.26

The CPRmeter 2 CPR feedback device is a portable, battery-powered device intended to provide real-time feedback on manual chest compression (i.e depth of compression) performed during cardiopulmonary resuscitation (CPR) on a patient in cardiac arrest, or during training on a resuscitation training model. It typically consists of a chest plate with a digital display, which is placed on the sternum and pushed down during chest compression and will display compression depth and rate, measured by one of various electronic technologies (e.g., electromagnetic signaling to a baseplate, accelerometer). It is intended to be used by those trained in CPR.

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LIX
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24

Record

Regulatory record for CPRmeter 2 (Multi-bundle)
Listed by	Laerdal Medical Corp., United States
FDA product code	LIX
Device type	Aid, Cardiopulmonary Resuscitation
Device class	Class 2
Regulation	21 CFR 870.5210
Record published	2016-11-28
Record revised	2019-01-03 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	serial number
Storage	Storage environment humidity 0 to 75 % RH; Storage environment temperature -20 to 70 °C

Catalogue Numbers

Catalogue numbers for CPRmeter 2 (Multi-bundle)
Catalogue number	Size	Status
801		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pocketcpr	Zoll Medical Corporation	3
Moore Medical	Moore Medical Corp.	2
TrueCPR™ Coaching Device	Physio-Control, Inc.	2
Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5	Zoll Medical Corporation	1
CPRmeter	Laerdal Medical Corp.	1
Onestep Pediaric CPR Multi-Function Electrode, SIN	Zoll Medical Corporation	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K183348	2018-12-17
K173886	2018-03-23
K151702	2015-08-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.