Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

NIBP cuff for adult, large (for attaching transmitter to patient arm)

Registry build 21.09.26
9manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRT
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Shenzhen Guangdong Specification developer 61
GE Medical Systems (China) Co., Ltd. Wuxi Jiangsu Contract manufacturer 57
Edan Instruments, Inc. Shenzhen Guangdong Contract manufacturer 56
Orantech Inc. Shenzhen Guangdong Contract manufacturer 40
Shenzhen Comen Medical Instruments Co., Ltd. Shenzhen Guangdong Contract manufacturer 24
Contec Medical Systems Co., Ltd. Qinhuangdao Hebei Manufacturer 22
Guangdong Biolight Meditech Co., Ltd. Zhuhai Guangdong Manufacturer 19

Record

Regulatory record for Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Listed by Nihon Kohden Corp., Japan
FDA product code DRT
Device type Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device class Class 2
Regulation 21 CFR 870.2300
Establishment Specification developer, Manufacturer
Record published 2016-09-05
Record revised 2024-03-04 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Catalogue number Size Status
ZS-940PA In distribution
ZM-531PA In distribution
ZM-541PA In distribution
ZM-520PA In distribution
BR-916PA In distribution
YP-943P Adult In distribution
YP-944P Adult, Large In distribution
YP-503P Adult In distribution
ZM-521PA In distribution
ZM-540PA In distribution
YP-504P Adult, Large In distribution
ZM-530PA In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Model 7600 IVY Biomedical Systems, Inc. 82
Model 7800 IVY Biomedical Systems, Inc. 66
ECG Zoll Medical Corporation 30
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Nihon Kohden America, Inc. 18
Model 7600EP IVY Biomedical Systems, Inc. 11
Propaq M Zoll Medical Corporation 11
Model 7700 IVY Biomedical Systems, Inc. 11
CTM-300 IVY Biomedical Systems, Inc. 6
Cable Zoll Medical Corporation 5
Upmm IVY Biomedical Systems, Inc. 4
ViSi Sotera Wireless 4
Anybattery Anybattery, Inc 3

Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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