Infant Phototherapy Equipment

GUDID 18800012345002

This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.

Bistos Co., Ltd.

Overhead infant phototherapy unit
Primary Device ID18800012345002
NIH Device Record Key5c061a3d-c56a-495a-a570-7f71f560b533
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfant Phototherapy Equipment
Version Model NumberBT-450
Company DUNS689908411
Company NameBistos Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800012345005 [Primary]
GS118800012345002 [Package]
Contains: 08800012345005
Package: Carton Box [8 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBIUnit, Neonatal Phototherapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-16
Device Publish Date2021-06-08

Devices Manufactured by Bistos Co., Ltd.

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18800012345002 - Infant Phototherapy Equipment2021-06-16This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home. The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
18800012345002 - Infant Phototherapy Equipment2021-06-16 This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice,
08800012341007 - N/A2021-06-15 This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injur
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