Cochlear™ MRI Kit

Basic Information

• Brand Name: Cochlear™ MRI Kit
• Primary DI: 09321502065924
• Version / Model: P1890818
• Catalog Number: P1890818
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 1
• Public Version Date: 2022-08-18
• Public Version Status: New
• Public Device Record Key: 53dfbfee-9f04-4129-8245-fbcb2bbedd9a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
PFO	Active implantable bone conduction hearing system	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38371	Facility magnetic field shielding material	A radiation protection device in the form of magnetically conductive material used in conjunction with medical devices in a medical facility, to form a barrier to contain magnetic field lines, and protect people or electronic equipment from magnetic effects. This kind of shielding is intended to permit electronic equipment to be operated closer than otherwise possible to large magnetic fields, e.g., those associated with magnetic resonance imaging (MRI) systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502065924	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220922	000