Vital Signs™

Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Single, 3.6 m/12 ft.

Registry build 21.09.26
9manufacturers in China registered for this device type
23catalogue numbers in this listing

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 Vital Signs™
Listed by AirLife Finland Oy, Finland
FDA product code MHX
Device type Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class Class 2
Regulation 21 CFR 870.1025
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer
Record published 2020-12-01
Record revised 2026-05-08 (version 6)

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Storage Storage environment temperature -22 to 140 °F
Distribution end date 2026-05-07

Catalogue Numbers

Catalogue numbers for Vital Signs™
Catalogue number Size Status
2021196-001 In distribution
2021197-003 In distribution
2021197-003 In distribution
2021700-001 In distribution
2021197-001 In distribution
2021700-001 In distribution
2016995-001 In distribution
2016997-001 In distribution
2016998-001 In distribution
2021197-001 In distribution
2016997-003 In distribution
2021196-001 In distribution
2005772-001 In distribution
2021196-003 In distribution
2016998-001 In distribution
2005772-001 In distribution
2021196-003 In distribution
2016997-001 In distribution
2016998-001 In distribution
2016995-003 In distribution
2021700-001 In distribution
2025248-002 Withdrawn
2025248-001 Withdrawn

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
Patient Monitor Edan Instruments, Inc. 22
Telemetry Accessories Philips Medizin Systeme Böblingen GmbH 21
Spacelabs Healthcare Spacelabs Healthcare (Washington), Inc 20

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

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