Plexa ProMRI

Basic Information

• Brand Name: Plexa ProMRI
• Primary DI: 04035479151027
• Version / Model: DF-1 S DX 65/15
• Catalog Number: 414005
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-27
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: f7fd35f0-8334-4ea6-9138-6629cd1b55e0

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NVY	Permanent defibrillator electrodes	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35853	Endocardial defibrillation lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04035479151027	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P980023	075

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Distance tip-atrial dipole: 150 mm
Device Size Text, specify			Length: 65 cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Store at temperatures up to 77¿F; excursions permitted from 41¿F to 131¿F