FDA.reportPublic FDA data

BiliCocoon™ Nest System

Primary DI
03760012570171
Brand
BiliCocoon™ Nest System
Company
NEOMEDLIGHT
Model
BCC101
Catalog number
BCC101
Published
2026-04-27
Public version status
New
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
K163526000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163526000Bilicocoon™ Phototherapy SystemNeomedlight2017-10-06LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760012570010PreviousGS10
03760012570171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760012570010037600125700103760012570010
03760012570171037600125701713760012570171

GMDN Terms#

Term, Definition table
TermDefinition
Blanket/pad infant phototherapy unitA device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a light source that connects to a blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. It is intended for use in the home and a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure50.4 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Degrees Celsius90 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
265910339
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760012570102BiliCocoon™ Light BoxBCC010BCC0102026-04-27
03760012570126BiliCocoon™ Bag SystemBCC2012026-04-27
03760012570133BiliCocoon™ Bag DisposableBCC221BCC2212026-04-27
03760012570188BiliCocoon™ Nest PadBCC111BCC1112026-04-27
03760012570195BiliCocoon™ Nest DisposableBCC121BCC1212026-04-27
03760012570218BiliCocoon™ Fixation SystemBCC301BCC3012026-04-27
03760012570225BiliCocoon™ Service KitBCC010-SK10BCC010-SK102026-04-27
03760012570249BiliCocoon™ Bag PadBCC211BCC2112026-04-27
03760012570003BiliCocoon™ Light BoxBCC010BCC0102017-11-03
03760012570010BiliCocoon™ Nest SystemBCC101BCC1012017-11-03
03760012570027BiliCocoon™ Nest PadBCC111BCC1112017-11-03
03760012570058BiliCocoon™ Bag SystemBCC201BCC2012017-11-03
03760012570065BiliCocoon™ Bag PadBCC211BCC2112017-11-03
03760012570096BiliCocoon™ Fixation SystemBCC301BCC3012017-11-03
03760012570119BiliCocoon™ Service KitBCC010-SK10BCC010-SK102017-11-03
03760012570041BiliCocoon™ Nest DisposableBCC121BCC1212017-11-03
03760012570089BiliCocoon™ Bag DisposableBCC221BCC2212017-11-03

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
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
00810101280405bili-hut™LITTLE SPARROWS TECHNOLOGIES LLCLBI2022-03-10