FDA.reportPublic FDA data

bili-hut™

Primary DI
00850019925517
Brand
bili-hut™
Company
LITTLE SPARROWS TECHNOLOGIES LLC
Model
0130A
Published
2022-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LBIUnit, Neonatal Phototherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBIUnit, Neonatal PhototherapyGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190899000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190899000bili-hutLittle Sparrows Technologies, Inc.2019-09-05LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019925517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019925517008500199255178500199255170850019925517

GMDN Terms#

Term, Definition table
TermDefinition
Overhead infant phototherapy unitA mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078764736
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810101280498bili-ruler00203A2026-04-07
00810101280559garden friendslarge butterfly0503LB2025-12-01
00810101280566garden friendssmall butterfly0504SB2025-12-01
00810101280573garden friendsinch worm0505IW2025-12-01
00810101280580garden friendscaterpillar0506CT2025-12-01
00810101280603bili-hut™ disposable nest mattress cover0182NMC2025-11-25
00810101280504bili-hut™ fully disposable nest & mattress (5-Pack)0133AFD52024-03-26
00810101280542bili-hut™ fully disposable convenience kit (5-Pack) 0133FDK52024-03-26
00810101280023bili-hut™0130A2022-03-10
00810101280047bili-hut™0130A2022-03-10
00810101280054bili-hut™0130A2022-03-10
00810101280405bili-hut™0130A2022-03-10
00810101280412bili-hut™ fully disposable nest & mattress0133AFD32022-03-10
00810101280436bili-hut™ disposable nest liner & mattress0133ADL52022-03-10
00810101280443bili-hut™ nest frame with disposable nest liner & mattress0103BDL2022-03-10
00810101280450bili-hut™ perch0108A2022-03-10
00850019925036bili-hut™0130A2022-03-10
00850019925357bili-hut™0130A2022-03-10
00850019925364bili-hut™0130A2022-03-10
00850019925371bili-hut™0130A2022-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760012570102BiliCocoon™ Light BoxNEOMEDLIGHTLBI2026-04-27
03760012570126BiliCocoon™ Bag SystemNEOMEDLIGHTLBI2026-04-27
03760012570133BiliCocoon™ Bag DisposableNEOMEDLIGHTLBI2026-04-27
03760012570171BiliCocoon™ Nest SystemNEOMEDLIGHTLBI2026-04-27
03760012570188BiliCocoon™ Nest PadNEOMEDLIGHTLBI2026-04-27
03760012570195BiliCocoon™ Nest DisposableNEOMEDLIGHTLBI2026-04-27
03760012570218BiliCocoon™ Fixation SystemNEOMEDLIGHTLBI2026-04-27
03760012570225BiliCocoon™ Service KitNEOMEDLIGHTLBI2026-04-27
03760012570249BiliCocoon™ Bag PadNEOMEDLIGHTLBI2026-04-27
05713315011252NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011269NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011276NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011283NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011313NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011351NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011405NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011849NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011856NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
05713315011863NeoBLUE blanket LED PhototherapyNatus Medical Denmark ApSLBI2026-01-22
00810101280603bili-hut™ disposable nest mattress coverLITTLE SPARROWS TECHNOLOGIES LLCLBI2025-11-25
05713315011214NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
05713315011221NeoblueNatus Medical Denmark ApSLBI2025-05-27
05713315011238NeoBLUE NovaNatus Medical Denmark ApSLBI2025-05-27
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPADVANCED INSTRUMENTATIONS, INC.LBI2025-02-07
00810101280504bili-hut™ fully disposable nest & mattress (5-Pack)LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280542bili-hut™ fully disposable convenience kit (5-Pack) LITTLE SPARROWS TECHNOLOGIES LLCLBI2024-03-26
00810101280023bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280047bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10
00810101280054bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10