What is FDA product code NHK?

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.

Anesthesiology › TherapeuticResuscitator, Manual, Non Self-Inflating

Breathing Bag

Name: Breathing Bag
Brand: 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.

Registry build 21.09.26

2manufacturers in China registered for this device type

4catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code NHK
Manufacturer	City	Province	Registered as	Device types
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33

Record

Regulatory record for Breathing Bag
Listed by	Mercury Medical Enterprises, LLC, United States
FDA product code	NHK
Device type	Resuscitator, Manual, Non Self-Inflating
Device class	Class 2
Regulation	21 CFR 868.5905
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
510(k)	K001714
Record published	2018-08-30

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Pack of 20

Catalogue Numbers

Catalogue numbers for Breathing Bag
Catalogue number	Size	Status
10-55395		In distribution
10-55393		In distribution
10-55391		In distribution
10-55392		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ventlab	Ventlab, LLC	129
Hyperinflation System	Mercury Medical Enterprises, LLC	64
Portex	ICU Medical, Inc	45
NuFLO2 Hyperinflation System	Mercury Medical Enterprises, LLC	44
Venti.Plus	Galemed Corp.	6
Venti.Plus	GaleMed (Xiamen) Co., Ltd.	4
Endure Industries	Endure Industries, Inc.	2
Disposable Medical Hyperinflation System	SunMed Group Holdings, LLC	2
Curaplex	Bound Tree Medical, LLC	1
Ventlab Hyperinflation System	Ventlab, LLC	1
Hyperinflation	Mercury Medical Enterprises, LLC	1

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.