Hi-bebe

GUDID 00887529000199

BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal heart sound through built-in speaker.

Bistos Co., Ltd.

Foetal Doppler system
Primary Device ID00887529000199
NIH Device Record Keya502361f-ae16-4b30-86fe-7d4cb36617c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameHi-bebe
Version Model NumberBT-200C
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 TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100887529000199 [Primary]
GS100887529000335 [Package]
Package: Gift Box [1 Units]
In Commercial Distribution
GS110887529000196 [Package]
Package: Gift Box [1 Units]
In Commercial Distribution
GS130887529000190 [Package]
Contains: 10887529000196
Package: Carton Box [10 Units]
In Commercial Distribution
GS140887529000197 [Package]
Contains: 10887529000196
Package: Carton Box [20 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 Number3
Public Version Date2018-07-06
Device Publish Date2018-03-16

On-Brand Devices [Hi-bebe]

00887529000199BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal he
30887529000039BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal he
30887529000022BT-200 is a pocket-size fetal Monitor that measures the fetal heat rate and outputs the fetal he

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