Reocor D

Basic Information

• Brand Name: Reocor D
• Primary DI: 04035479110055
• Version / Model: 365529
• Catalog Number: 365529
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-13
• Public Version: 4
• Public Version Date: 2018-10-05
• Public Version Status: Update
• Public Device Record Key: 2e6f6248-8d9f-4ff0-ba4c-2fbff3ab3a93

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: Yes
• Has Lot/Batch Number: No
• 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
OVJ	Pulse generator, external pacemaker, dual-chamber	Cardiovascular	870.3600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35822	External pacemaker, transcutaneous pacing	An external pulse generator (EPG) designed to generate electrical cardiac pacing impulses to stimulate the entire heart simultaneously (in contrast to single- or dual-chambered invasive pacing) to resuscitate the patient, restore normal cardiac rhythm, and/or temporarily pace the heart during invasive procedures that may induce cardiac arrhythmias or asystole (cardiac standstill). The electrical impulses from the device are usually applied to the surface of the chest through cutaneous leads/electrodes (transcutaneous cardiac stimulation).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479110055	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P950037	084

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit