Product code NHK

Device name: Resuscitator, Manual, Non Self-Inflating
Medical specialty: Anesthesiology
Device class: 2
Regulation number: 868.5905
Review panel: AN
Implant: N
Life sustaining/supporting: Y
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: 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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K092687	VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER	A Plus Medical	2009-11-23
K020281	MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM	Ventlab Corp.	2002-02-11
K013308	VENTLAB HYPERINFLATION BAG SYSTEM	Ventlab Corp.	2001-12-20
K001714	MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149	Mercury Medical	2000-11-03
K970785	SIMS HYPERINFLATION BAG SYSTEM	Sims	1997-06-13
K952214	SIMS INTERTECH HYPERINFLATION BAG SYSTEM	Intertech Resources, Inc.	1995-06-08
K942571	HYPER-INFLATION BAG	Med-Plastics Intl., Inc.	1994-06-10
K940255	HYPERINFLATION BAG SYSTEM	Nutec, Inc.	1994-02-17
K894612	INTERTECH NEWBORN HYPERINFLATION BAG SYSTEM	Intertech Resources, Inc.	1989-09-08
K813317	DISP. HYPERINFLATION BAG SYSTEM	Intec Medical, Inc.	1982-03-12

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
10351688420503	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423306	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423290	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423283	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423276	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423269	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423252	Portex	ICU MEDICAL, INC.	2015-09-01
10351688423245	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420626	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420619	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420589	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420572	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420541	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420527	Portex	ICU MEDICAL, INC.	2015-09-01
10351688420510	Portex	ICU MEDICAL, INC.	2015-09-01
10351688403278	Portex	ICU MEDICAL, INC.	2015-09-01
10351688416834	Portex	ICU MEDICAL, INC.	2015-09-01
10351688416407	Portex	ICU MEDICAL, INC.	2015-09-01
10351688413673	Portex	ICU MEDICAL, INC.	2015-09-01
10351688411754	Portex	ICU MEDICAL, INC.	2015-09-01
10351688411747	Portex	ICU MEDICAL, INC.	2015-09-01
10351688407573	Portex	ICU MEDICAL, INC.	2015-09-01
10351688406866	Portex	ICU MEDICAL, INC.	2015-09-01
10351688406446	Portex	ICU MEDICAL, INC.	2015-09-01
10351688406392	Portex	ICU MEDICAL, INC.	2015-09-01
10351688405784	Portex	ICU MEDICAL, INC.	2015-09-01
10351688404435	Portex	ICU MEDICAL, INC.	2015-09-01
10351688404213	Portex	ICU MEDICAL, INC.	2015-09-01
10351688403933	Portex	ICU MEDICAL, INC.	2015-09-01
10351688416940	Portex	ICU MEDICAL, INC.	2015-07-29

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