My Baby's Heartbeat Bear Fetal Doppler

Basic Information

• Brand Name: My Baby's Heartbeat Bear Fetal Doppler
• Primary DI: 06970442090324
• Version / Model: FD-590G
• Company Name: Vcomin Technlogy Limited
• Labeler DUNS: 548312355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-25
• Public Version: 2
• Public Version Date: 2023-08-09
• Public Version Status: Update
• Public Device Record Key: ffc99d89-99eb-4798-ac00-0e8f3b6adb2f

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	884.2660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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	16970442090321	GS1	box	30	In Commercial Distribution
Primary	06970442090324	GS1

Premarket Submissions

Submission Number	Supplement Number
K182526	000