R2

Basic Information

• Brand Name: R2
• Primary DI: 10653405001225
• Version / Model: 32-184572X
• Catalog Number: 32-184572X
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a442e618-7ff9-4c98-aac6-1dd25fa66675

Device Description

R2 MULTIFUNCTION ELECTRODE ACCESSORIES, HEARTSTART XL TO R2 MULTIFUNCTION CABLE

Device Characteristics

• Single Use: No
• 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: No
• 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
LDD	Dc-defibrillator, low-energy, (including paddles)	Cardiovascular	870.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37423	Pin-indexed adaptor, reusable	A connecting device intended to join two incompatible devices/components through a system of uniquely coded pins, slots, or holes which match when united, and provide security against the inadvertent coupling of devices other than a specific pair. The device is often used to connect an anaesthetic agent container to its dedicated vapourizer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10653405001225	GS1

Customer Contacts

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