N/A - BEUDAMED

Basic Information

Brand Name: N/A
Primary DI: 00887529000069
Version / Model: BT-350E
Catalog Number: MKT-350-1509
Company Name: Bistos Co., Ltd.
Labeler DUNS: 689908411
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-03
Public Version: 6
Public Version Date: 2022-11-28
Public Version Status: Update
Public Device Record Key: 2c87c938-bd3d-440e-8f90-0ee9981a5a06

Device Description

BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Using these parameters, the medical team can monitor fetal status and check uterine contraction degree.

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
37258	Tocodynamometer probe	A pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.	No	Active
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
37796	Foetal/maternal prenatal monitor	An electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status
Package	10887529000066	GS1	Carton Box	1	In Commercial Distribution
Primary	00887529000069	GS1
Package	00887529000304	GS1	Carton Box	1	In Commercial Distribution

Customer Contacts

Phone: 949-614-8745
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K103545	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