FDA.reportPublic FDA data

Well Baby Bassinet

Primary DI
00840682119337
Brand
Well Baby Bassinet
Company
DATEX-OHMEDA INC
Model
BN7
Device description
ASSY-LAU, BASSINET WITH TUB MED OAK,, WITH LABELS MANUFACTURING ASSEMBLY - MAKE
Published
2016-07-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840682119337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682119337008406821193378406821193370840682119337

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
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131483356
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682119320Well Baby BassinetBN42016-07-29
00840682119344Well Baby BassinetBN32016-07-29
00840682119375Well Baby BassinetBN12016-07-29
00840682119399Well Baby BassinetBN22016-07-29
00840682119429Well Baby BassinetBN62016-07-29
00840682119436Well Baby BassinetBN92016-07-29
00840682119467Well Baby BassinetBN82016-07-29
00840682119481Well Baby BassinetBN102016-07-29
00840682119498Well Baby BassinetBN52016-07-29
00840682102353Aestiva GS7900 2 vap art arm2015-09-23
00840682102261Aespire79002015-09-23
00840682102285AespireView2015-09-23
00840682102308Aestiva79002015-09-23
00840682102339AestivaMRI2015-09-23
00840682102360Aestiva GS7900 3 vap art arm2015-09-23
00840682145596Carestation 750A12023-04-04
00840682146425Carestation 750cA12023-04-04
00195278579157ET CONTROL OPTIONAISYS CS22022-07-21
00195278588128AisysCS2 WITH ET CONTROL2022-07-21
00840682102322AvanceCS22015-09-23

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