FDA.reportPublic FDA data

Bassinest

Primary DI
00818771039606
Brand
Bassinest
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
2018-08-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMSBed, Pediatric Open Hospital
NZGBassinet, Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMSBed, Pediatric Open HospitalGeneral Hospital2
NZGBassinet, HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818771000002PrimaryGS10
00818771039606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

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.

Sterilization Methods#

Method table
Method

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
00818771000002Bassinest Hospital Series39572019-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623284Double Tier Tray Outer ShellMAKO SURGICAL CORP.FMS2026-01-30
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
08592654433973Tom 2L I N E T spol. s r.o.FMS2024-02-23
00850022426773C1983CGNOVUM MEDICAL PRODUCTS INCFMS2024-02-14
00850022426766C2080FWCRNOVUM MEDICAL PRODUCTS INCFMS2024-01-12
08592654351956Tom 2L I N E T spol. s r.o.FMS2023-12-11
08592654389690Tom 2L I N E T spol. s r.o.FMS2023-04-14
00850022426650C2083CGNOVUM MEDICAL PRODUCTS INCFMS2023-02-16
00850022426643C2072CLNOVUM MEDICAL PRODUCTS INCFMS2022-11-17
08592654376386Tom 2L I N E T spol. s r.o.FMS2022-11-16
00850022426636C1981CGTNOVUM MEDICAL PRODUCTS INCFMS2022-11-15
08592654289884Tom 2L I N E T spol. s r.o.FMS2022-04-29
08592654353882Tom 2L I N E T spol. s r.o.FMS2022-04-29
00850038811945Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811952Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811969Coleman BassinetBlickman Industries, LLCNZG2022-04-11
00850038811976Coleman BassinetBlickman Industries, LLCNZG2022-04-11
08592654348000Tom 2L I N E T spol. s r.o.FMS2022-02-28
08592654345450Tom 2L I N E T spol. s r.o.FMS2022-01-21
00850022426513NB-WFXD-3DL-BRSNOVUM MEDICAL PRODUCTS INCNZG2021-08-16
00724995204495BirkovaSTERIS CORPORATIONNZG2021-06-30
00724995204501BirkovaSTERIS CORPORATIONNZG2021-06-30