Bilisoft 2.0

Primary DI
00812432020453
Brand
Bilisoft 2.0
Company
Lumitex, Inc.
Model
009791
Device description
The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Published
2018-11-15
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
K053568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053568000BILISOFT PHOTOTHERAPY SYSTEMLumitex, Inc.2006-04-17LBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812432020453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812432020453008124320204538124320204530812432020453

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 fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent 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. This device can be suitable for home-use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108631797
Device count
1
Serial number
true
Manufacturing date on label
true

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