FDA.reportPublic FDA data

Nara

Primary DI
07613327261653
Brand
Nara
Company
STRYKER CORPORATION
Model
4402
Catalog number
4402-000-002
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NZGBassinet, hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZGBassinet, HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327261653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327261653076133272616537613327261653

GMDN Terms#

Term, Definition table
TermDefinition
Newborn-infant bedA bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284746916Couplet Care BassinetCouplet Care, Inc.NZG2026-01-21
00841027102656Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102663Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102670Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102687Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102694Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00841027102700Pedigo Products, Inc. PEDIGO PRODUCTS, INC.NZG2025-11-26
00852788008101NeoLight Bassinet Basket LoanerNEOLIGHT LLCNZG2025-04-09
00852788008217NeoLight Bassinet BasketNEOLIGHT LLCNZG2024-12-31
00850038811945Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811952Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811969Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811976Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850022426513NB-WFXD-3DL-BRSNOVUM MEDICAL PRODUCTS INCNZG2021-08-16
00724995204495BirkovaSTERIS CORPORATIONNZG2021-06-30
00724995204501BirkovaSTERIS CORPORATIONNZG2021-06-30
00851477007265MedvironMEDVIRON LLCNZG2020-10-23
00851477007227MedvironMEDVIRON LLCNZG2020-05-05
00851477007234MedvironMEDVIRON LLCNZG2020-05-05
00851477007241MedvironMEDVIRON LLCNZG2020-05-05
00851477007258MedvironMEDVIRON LLCNZG2020-05-05
008509250077729000X17TNOVUM MEDICAL PRODUCTS INCNZG2020-02-25
07540162040009THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040016THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040023THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040030THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040047THE KERRI BEAR MATERNITY BASSINETImperial Surgical LtdNZG2019-08-07
07540162040054S/S Tubular frame maternity bassinetImperial Surgical LtdNZG2019-08-07
00887761995055BassinetHILL-ROM, INC.NZG2019-07-09
00850925007710NB-SSxBCNOVUM MEDICAL PRODUCTS INCNZG2019-05-23