IntelliVue MX40 1.4GHz

IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 1.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or Philips IntelliVue…

Registry build 21.09.26

IntelliVue MX40 Patient Worn Monitor operating on the IntelliVue 1.4 GHz Smart-hopping Network for communication to the Philips IntelliVue Information Center or Philips IntelliVue Information Center iX.

9manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code MHX
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
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
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
Shanghai Draeger Medical Instrument Co., Ltd. Shanghai Shanghai Contract manufacturer 4
General Meditech, Inc. Shenzhen Guangdong Complaint-file establishment 3

Record

Regulatory record for IntelliVue MX40 1.4GHz
Listed by Philips Medical Systems Hsg
FDA product code MHX
Device type Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class Class 2
Regulation 21 CFR 870.1025
Record published 2016-09-22
Record revised 2023-03-13 (version 10)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries serial number
Storage Storage environment temperature -20 to 50 °C; Storage environment atmospheric pressure 57 to 106 KiloPascal; Storage environment humidity 15 to 90 % RH

Catalogue Numbers

Catalogue numbers for IntelliVue MX40 1.4GHz
Catalogue number Size Status
MX40 1.4 GHz Smart Hopping In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fukuda Denshi Fukuda Denshi Co., Ltd. 326
Welch Allyn, Inc. Welch Allyn, Inc. 266
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Nihon Kohden Corp. 205
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Nihon Kohden America, Inc. 139
Surveyor Central Mortara Instrument, Inc. 71
Tempus Pro Remote Diagnostic Technologies Ltd. 44
Surveyor S12 Mortara Instrument, Inc. 38
Ultraview Spacelabs Healthcare (Washington), Inc 29
Surveyor S19 Mortara Instrument, Inc. 26
Vital Signs™ AirLife Finland Oy 23
Patient Monitor Edan Instruments, Inc. 22
Telemetry Accessories Philips Medizin Systeme Böblingen GmbH 21

Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of IntelliVue MX40 1.4GHz
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Philips North America LLC UDI-DI 2021-02-02 Class II Employee error Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices 3 units 2022-09-20

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