N/A MKT-500-1509

GUDID 10887529000134

BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.

Bistos Co., Ltd.

Conventional infant incubator
Primary Device ID10887529000134
NIH Device Record Keye15e2aa9-1f21-49cc-b168-d24482b5f0d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberBT-500
Catalog NumberMKT-500-1509
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
Emailfshurjoon@bistos.co.kr

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100887529000137 [Primary]
GS100887529000212 [Package]
Contains: 00887529000137
Package: Carton Box [1 Units]
In Commercial Distribution
GS110887529000134 [Package]
Contains: 00887529000137
Package: Carton Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMZIncubator, Neonatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-06-03

On-Brand Devices [N/A]

00887529000373This Head-worn light is used for medical examination by fixing it on the head and illuminating w
00887529000366This Head-worn light is used for medical examination by fixing it on the head and illuminating w
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10887529000134BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with s
10887529000110BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spec
10887529000103BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to pr
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30887529000084Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rate and out put
10887529000066BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
10887529000059BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
30887529000046Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out put
18800012341011This Head-worn light is used for medical examination by fixing it on the head and illuminating w
08800012341007This Head-worn light is used for medical examination by fixing it on the head and illuminating w

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