Respiratory Mechanics Sensor – Neonatal

Catalogue number 5957100, listed by Draeger Medical Systems, Inc., United States, under Calculator, Pulmonary Function Data. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BZC
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77

Record

Regulatory record for Respiratory Mechanics Sensor → Neonatal
Listed by Draeger Medical Systems, Inc., United States
FDA product code BZC
Device type Calculator, Pulmonary Function Data
Device class Class 2
Regulation 21 CFR 868.1880
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2015-11-02
Record revised 2024-08-07 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries manufacturing date

Catalogue Numbers

Catalogue numbers for Respiratory Mechanics Sensor → Neonatal
Catalogue number Size Status
5957100 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Jaeger Jaeger Medical GmbH 227
Vyaire Jaeger Medical GmbH 120
Vyntus Jaeger Medical GmbH 14
Innocor Innovision Medical Technologies, LLC 6
Vyntus Vyaire Medical, Inc. 3
Cosmed C O S M E D SRL 3
APS-Pro SA Jaeger Medical GmbH 3
MGC Diagnostics Medical Graphics Corp. 2
TransAir3 Medi Soft SA 1
MasterScreen PFT Jaeger Medical GmbH 1
SentrySuite Software Jaeger Medical GmbH 1
TrueOne 2400 Parvomedics, Incorporated 1

Showing 12 of 19. All products under Calculator, Pulmonary Function Data

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