What is FDA product code NZG?

Intended for medical purposes designed for the use of a pediatric patient made of all construction materials used in a hospital nursery.

General Hospital › TherapeuticBassinet, Hospital

Nara

Name: Nara
Brand: Nara

2 catalogue numbers from 4402, listed by Stryker GmbH, Switzerland, under Bassinet, Hospital. 4 manufacturers in China are registered for this product code.

Registry build 21.09.26

4manufacturers in China registered for this device type

2catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jiangsu (2), Hebei (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NZG
Manufacturer	City	Province	Registered as	Device types
Hebei Jiede Medical Equipment Co., Ltd.	Hengshui	Hebei	Contract manufacturer	20
Flying Tooling Engineering Limited	Dongguan	Guangdong	Contract manufacturer	9
Dragon Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	48
Jiangsu Yongfa Medical Equipment Technology Co., Ltd.	Zhangjiagang	Jiangsu	Manufacturer	33

Record

Regulatory record for Nara
Listed by	Stryker GmbH, Switzerland
FDA product code	NZG
Device type	Bassinet, Hospital
Device class	Class 2
Regulation	21 CFR 880.5145
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2016-09-23
Record revised	2022-06-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Handling environment humidity 20 to 85 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 20 to 85 % RH; Handling environment temperature 14 to 140 °F; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature 14 to 140 °F

Catalogue Numbers

Catalogue numbers for Nara
Catalogue number	Size	Status
4402		In distribution
4402		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pedigo Products, Inc.	Pedigo Products, Inc.	15
Medviron Bassinet	Medviron LLC	10
Well Baby Bassinet	Datex-Ohmeda, Inc.	10
Pedicraft	Pedicraft, Inc.	9
UMF Medical	United Metal Fabricators, Inc.	6
Amico Patient Care Corporation	Amico Patient Care Corporation	5
THE Kerri Bear Maternity Bassinet	Imperial Surgical Ltd.	5
Medviron	Medviron LLC	5
Coleman Bassinet	Blickman Industries LLC	4
Bassinet	Hill-ROM, Inc.	3
Birkova	Steris Corporation	2
Medviron St Clair Bassinet	Medviron LLC	1

Showing 12 of 22. All products under Bassinet, Hospital

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2018-10-10	Class II	Device Design	It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface and tub. A Health Hazard Evaluation was completed	5915	2020-04-29

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.