Medline

PAD, Defib, Adult, Radiotran, Physio, LO

Registry build 21.09.26
6manufacturers in China registered for this device type
15catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (3), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MLN
Manufacturer City Province Registered as Device types
Linxens Healthcare (Tianjin) Co., Ltd. Jinnan District Tianjin Contract manufacturer 7
Infitek Co., Ltd. Shanghai Shanghai Manufacturer 49
Labpeak Co., Ltd. Jinan Shandong Manufacturer 43
Scitek Global Co., Ltd. Jinan Shandong Manufacturer 43
Jiangsu Rooe Medical Technology Co., Ltd. Zhangjiagang Jiangsu Manufacturer 31
China Qingdao Bright Medical Manufacturing Co., Ltd. Qingdao Shandong Contract manufacturer 8

Record

Regulatory record for Medline
Listed by Medline Industries, Inc., United States
FDA product code MLN
Device type Electrode, Electrocardiograph, Multi-Function
Device class Class 2
Regulation 21 CFR 870.2360
Record published 2020-10-08
Record revised 2023-02-20 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number Size Status
MDSPHY200LO In distribution
MDST100AC In distribution
MDSPHY100LO In distribution
MDSPHY200 In distribution
MDSPHL100 In distribution
MDSZOL200LO In distribution
MDSPHL200 In distribution
MDSC200AC In distribution
MDSZOL200 In distribution
MDSPHL200LO In distribution
MDSC200LOAC In distribution
MDSZOL100LO In distribution
MDSZOL100 In distribution
MDST100LOAC In distribution
MDSPHY100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Regard™ Resource Optimization & Innovation, L.L.C. 25
Heartsync by Vermed Graphic Controls Acquisition Corporation 9
Curaplex Bound Tree Medical, LLC 6
Adult/Child, radiotransparent, defib electrodes with increased adhesive surface Heart Sync, LLC 6
Henry Schein Henry Schein, Inc. 3
MediChoice Owens & Minor Distribution, Inc. 3
Adult/Child, radiotransparent, leads out, defib electrodes w/ Phillips connector Heart Sync, LLC 3
Adult/Child, radiolucent, leads out, defib electrodes w/ Zoll connector Heart Sync, LLC 3
BodyGuardian Preventice Technologies, Inc. 3
Zensor electrode Intelesens Limited 2
Adult/Child, radiotransparent, defib electrodes w/ Zoll connector Heart Sync, LLC 2
Heart Sync Adult/Child Radio Transparent Multi Function Electrodes Heart Sync, LLC 2

Showing 12 of 24. All products under Electrode, Electrocardiograph, Multi-Function

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer