FDA.reportPublic FDA data

Bassinest Hospital Series

Primary DI
00818771000002
Brand
Bassinest Hospital Series
Company
HALO INNOVATIONS, INC.
Model
3957
Device description
The HALO Hospital Bassinest is designed to be a sleeping surface for infant/newborn patients. The top surface of the device raises and lowers to allow easier access to the infant/newborn. The HALO Hospital Bassinest was also designed for in-hospital transport within newborn labor/delivery units, postpartum units, medical surgical units treating high risk pregnancy patients, NICU’s, and any other patient areas within a hospital where a newborn infant may be treated and/or cared for during hospital admissions. This product is NOT INTENDED for patients that can crawl or reposition themselves independently
Published
2019-03-26
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
00818771039606PreviousGS10
00818771000002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818771039606008187710396068187710396060818771039606
00818771000002008187710000028187710000020818771000002

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal 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.

Regulatory Flags#

DUNS number
825255706
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818771039606Bassinest39572018-08-20

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