PURE ENRICHMENT

Basic Information

• Brand Name: PURE ENRICHMENT
• Primary DI: B311PEPEAK0
• Version / Model: PEPEAK
• Company Name: BEAR DOWN CONSULTING
• Labeler DUNS: 040869867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-15
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 2821efff-1603-4498-ba65-01469eb497e8

Device Description

Massager, therapeutic, electric

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36560	Hand-held electric massager	An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B311PEPEAK1	HIBCC	MASTER CARTON	40	In Commercial Distribution
Primary	B311PEPEAK0	HIBCC