PURE ENRICHMENT

Basic Information

• Brand Name: PURE ENRICHMENT
• Primary DI: B311PEFETDPL0
• Version / Model: PEFETDPL
• Company Name: BEAR DOWN CONSULTING
• Labeler DUNS: 040869867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a341b9c0-2744-4ac2-a8ad-644ead929b26

Device Description

Fetal Doppler. Used to hear heart rate sounds.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Manufacturing Date: No
• 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	B311PEFETDPL1	HIBCC	MASTER CARTON	20	In Commercial Distribution
Primary	B311PEFETDPL0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K131457	000