Hi-dop

Basic Information

• Brand Name: Hi-dop
• Primary DI: 00887529000014
• Version / Model: BT-200V
• Catalog Number: OSD-14200V-001
• Company Name: Bistos Co., Ltd.
• Labeler DUNS: 689908411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-14
• Public Version: 6
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 39299a8a-efad-4587-a71c-9ac6383c934a

Device Description

Bistos' BT-200V is a pocket size Ultrasound Doppler System, 2 MHz Ultrasound Doppler Probe that measure the fetal heart rate and outputs the Fetal Heart sound through built-in Speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-200V irradiates fetal wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus. 4, 5, 8 MHz Ultrasound Doppler probe that measures the vascular pulse rate and outputs the blood flow sound through built-in speaker. By measuring pulse rate(PR) they are able to check vascular blood flow status. BT-200V irradiates vascular wave to the patient skin to detect the Doppler frequency signal and analyze to displays the pulse rate on LCD screen. The device also provides the blood flow sound from the patient.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41917	Foetal Doppler system probe	A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). This is a reusable device.	No	Active
34040	Foetal Doppler system	A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30887529000015	GS1	Carton Box	10	In Commercial Distribution
Package	10887529000011	GS1	Gift Box	1	In Commercial Distribution
Primary	00887529000014	GS1
Package	20887529000018	GS1	Carton Box	5	In Commercial Distribution
Package	00887529000267	GS1	Gift Box	1	In Commercial Distribution
Package	40887529000012	GS1	Carton Box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121267	000

Storage Conditions

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