Bio Protech

Basic Information

• Brand Name: Bio Protech
• Primary DI: 00817120021064
• Version / Model: RMC100 (Lifelines)
• Company Name: BIO PROTECH USA, INC.
• Labeler DUNS: 789127011
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6f304b1a-c580-46c6-8b27-f6639a527325

Device Description

RMC100 (Lifelines) - Lifelines OEM, Cables for Needle Electrodes, 1m length, 1.5mm (DIN 42 802), 1 per pack/ 200 per master case

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817120021061	GS1	Master Case	200	In Commercial Distribution
Primary	00817120021064	GS1

Customer Contacts

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