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
07613327631388N/A50275000005027-500-0002026-06-16
07613327631395N/A50275001005027-500-1002026-06-19
07613327632774N/A50275004005027-500-4002026-06-16
07613327651119VersiQuad0234112012234-112-0122026-07-16
07613327651126VersiQuad0234112611234-112-6112026-07-16
07613327651133VersiQuad0234112100234-112-1002026-07-16
07613327651140VersiQuad0234112608234-112-6082026-07-16
07613327651157VersiQuad0234112109234-112-1092026-07-16
07613327651164VersiQuad0234112500234-112-5002026-07-16
07613327651171VersiQuad0234112108234-112-1082026-07-16
07613327651195VersiQuad0234112607234-112-6072026-07-16
07613327651201VersiQuad0234112110234-112-1102026-07-16
07613327651218VersiQuad0234112609234-112-6092026-07-16
07613327651225VersiQuad0234112610234-112-6102026-07-16
07613327507935Stroke Fast PackSFP913140SFP9131402020-06-30
07613327507942Stroke Fast PackSFP913150SFP9131502020-06-30
07613327507959Stroke Fast PackSFP913160SFP9131602020-06-30
07613327507966Stroke Fast PackSFP913170SFP9131702020-06-30
07613327507973Stroke Fast PackSFP913180SFP9131802020-06-30
07613327507980Stroke Fast PackSFP913190SFP9131902020-06-30

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