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.

Cardiotocograph transducer

• Primary Device ID: 10887529000103
• NIH Device Record Key: 1f30ef95-46bf-402c-9c27-7ebd6a064e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: BT-300
• Catalog Number: OSD-15300-001
• Company DUNS: 689908411
• Company Name: Bistos Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr
• Phone: 949-614-8745
• Email: fshurjoon@bistos.co.kr

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887529000106 [Primary]
GS1	00887529000250 [Package]; Contains: 00887529000106; Package: Carcon Box [1 Units]; In Commercial Distribution
GS1	10887529000103 [Package]; Contains: 00887529000106; Package: Carton Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052190

FDA Product Code

• HGM: System, Monitoring, Perinatal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-14

On-Brand Devices [N/A]

• 00887529000373: This Head-worn light is used for medical examination by fixing it on the head and illuminating w
• 00887529000366: This Head-worn light is used for medical examination by fixing it on the head and illuminating w
• 10887529000189: Cart for BT-400 Neonatal phototherapy
• 10887529000134: BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with s
• 10887529000110: BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spec
• 10887529000103: BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to pr
• 30887529000091: Bistos’ BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put
• 30887529000084: Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rate and out put
• 10887529000066: BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
• 10887529000059: BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
• 30887529000046: Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out put
• 18800012341011: This Head-worn light is used for medical examination by fixing it on the head and illuminating w
• 08800012341007: This Head-worn light is used for medical examination by fixing it on the head and illuminating w