RICHMAR

Basic Information

• Brand Name: RICHMAR
• Primary DI: 00813520010240
• Version / Model: WW3005
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 4
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 98b9efc4-cc2a-4b52-b5e4-e84fb75e0aa6

Device Description

Lead Wire - Standard 45

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	01813520010249	GS1
Package	80813520010246	GS1	CA	500	In Commercial Distribution
Primary	00813520010240	GS1
Unit of Use	91813520010242	GS1

Customer Contacts

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