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

Onestep Pediaric CPR Multi-Function Electrode, SIN · Aid, Cardiopulmonary Resuscitation → Cardiovascular

Name: Onestep Pediaric CPR Multi-Function Electrode, SIN
Brand: Onestep Pediaric CPR Multi-Function Electrode, SIN

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Onestep Pediaric CPR Multi-Function Electrode, SIN
Listed by	Zoll Medical Corporation, United States
FDA product code	LIX
Device type	Aid, Cardiopulmonary Resuscitation
Device class	Class 2
Regulation	21 CFR 870.5210
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2015-07-20
Record revised	2022-02-08 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 0 to 35 °C; Handling environment temperature 0 to 50 °C

Catalogue Numbers

Catalogue numbers for Onestep Pediaric CPR Multi-Function Electrode, SIN
Catalogue number	Size	Status
8900-000231-01	8.5″ (w) X 9.875″ (l) X 1.5″ (h)	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 2 (Multi-bundle)	Laerdal Medical Corp.	1
CPRmeter	Laerdal Medical Corp.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K112660	2012-05-10

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.

Onestep Pediaric CPR Multi-Function Electrode, SIN