Wireless Programming Pod CP1000

Basic Information

• Brand Name: Wireless Programming Pod CP1000
• Primary DI: 09321502038164
• Version / Model: Z597944
• Catalog Number: Z597944
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-07
• Public Version: 6
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: 465b96cb-b0ee-427a-8767-96a951c94998

Device Description

CP1000

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61462	Hearing aid/implant system programming interface unit	A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502038164	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	151

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius