N/A OSD-15300-001

GUDID 10887529000103

BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus.

Bistos Co., Ltd.

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Primary Device ID10887529000103
NIH Device Record Key1f30ef95-46bf-402c-9c27-7ebd6a064e1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberBT-300
Catalog NumberOSD-15300-001
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
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr
Phone949-614-8745
Emailfshurjoon@bistos.co.kr

Operating and Storage Conditions

Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100887529000106 [Primary]
GS100887529000250 [Package]
Contains: 00887529000106
Package: Carcon Box [1 Units]
In Commercial Distribution
GS110887529000103 [Package]
Contains: 00887529000106
Package: Carton Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, Monitoring, Perinatal

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 Date2016-06-14

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
10887529000189Cart for BT-400 Neonatal phototherapy
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
30887529000091Bistos’ BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put
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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