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

Ventlab Hyperinflation System

Name: Ventlab Hyperinflation System
Brand: Ventlab Hyperinflation System

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

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

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 Ventlab Hyperinflation System
Listed by	Ventlab, LLC, United States
FDA product code	NHK
Device type	Resuscitator, Manual, Non Self-Inflating
Device class	Class 2
Regulation	21 CFR 868.5905
Record published	2026-06-24

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, manufacturing date, serial number
Packaging	Pack of 20

Catalogue Numbers

Catalogue numbers for Ventlab Hyperinflation System
Catalogue number	Size	Status
HS4051-W		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
Breathing Bag	Mercury Medical Enterprises, LLC	4
Endure Industries	Endure Industries, Inc.	2
Disposable Medical Hyperinflation System	SunMed Group Holdings, LLC	2
Curaplex	Bound Tree Medical, LLC	1
Hyperinflation	Mercury Medical Enterprises, LLC	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K020281	2002-02-11
K013308	2001-12-20

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.