Resuscitator, Manual, Non Self-Inflating

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Fujian and Guangdong. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

GaleMed (Xiamen) Co., Ltd. Fujian, contract manufacturer
Sunmed AP, Ltd. Guangdong, contract manufacturer

What Is It?

A non self-inflating manual resuscitator, also called a hyperinflation system, is a manual ventilator intended to ventilate a patient by forcing a volume of fresh gas into the patient via compression of the ventilator bag; a source of compressed breathing gas is required to inflate the bag.

How Is NHK Classified?

Resuscitator, Manual, Non Self-Inflating is FDA product code NHK, Class 2, 21 CFR 868.5905.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

Resuscitator, Manual, Non Self-Inflating

Hyperinflation

Catalogue number 10-55870, listed by Mercury Medical Enterprises, LLC, United States, under Resuscitator, Manual, Non Self-Inflating. 2 manufacturers in China are registered for this product code.

Resuscitator, Manual, Non Self-Inflating

Ventlab Hyperinflation System

.5L Hyperinflation System + Manometer + 40cm/H2O Pop-Off + Large Thumbwheel

Resuscitator, Manual, Non Self-Inflating

Disposable Medical Hyperinflation System

AirLife™ Hyperinflation System, Transport Elbow, 8' Oxygen Tubing with Threaded Nut

Resuscitator, Manual, Non Self-Inflating

Endure Industries

PVC Resuscitator, Disposable, Pediatric

Resuscitator, Manual, Non Self-Inflating

Curaplex

Curaplex Resuscitation Training Kit

Resuscitator, Manual, Non Self-Inflating

Breathing Bag

4 catalogue numbers from 10-55395, listed by Mercury Medical Enterprises, LLC, United States, under Resuscitator, Manual, Non Self-Inflating. 2 manufacturers in China are registered for this product code.

Resuscitator, Manual, Non Self-Inflating

Venti.Plus

6 catalogue numbers from H050-M, listed by Galemed Corp., Taiwan, under Resuscitator, Manual, Non Self-Inflating. 2 manufacturers in China are registered for this product code.

Resuscitator, Manual, Non Self-Inflating

Venti.Plus

1.0 Hyperinflation W/ Manmtr, Mask

Resuscitator, Manual, Non Self-Inflating

Hyperinflation System

Hyperinflation System with 3L breathing bag

Resuscitator, Manual, Non Self-Inflating

NuFLO2 Hyperinflation System

44 catalogue numbers from 10-56801, listed by Mercury Medical Enterprises, LLC, United States, under Resuscitator, Manual, Non Self-Inflating. 2 manufacturers in China are registered for this product code.

Resuscitator, Manual, Non Self-Inflating

Ventlab

Ventlab’s hyperinflation system is a manual breathing-bag assembly used to deliver controlled positive-pressure breaths through a face mask. The listed set specifies a half-liter bag,…

Resuscitator, Manual, Non Self-Inflating

Portex

45 catalogue numbers from 8518, listed by ICU Medical, Inc, United States, under Resuscitator, Manual, Non Self-Inflating. 2 manufacturers in China are registered for this product code.

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