Cochlear P1348428

GUDID 09321502044905

Osia™ Fitting Software 2

COCHLEAR LIMITED

Audiometric/hearing device software

• Primary Device ID: 09321502044905
• NIH Device Record Key: 0b1f27e8-46d3-4b9a-be41-70c45ca6d63c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear
• Version Model Number: P1348428
• Catalog Number: P1348428
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502044905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191921

FDA Product Code

• PFO: Active implantable bone conduction hearing system

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-11-03
• Device Publish Date: 2019-11-23

On-Brand Devices [Cochlear]

• 09321502044103: COCHLEAR CP1000 COMPACT AQUA+, PACKED
• 09321502044080: COCHLEAR NUCLEUS 7 HEADBAND, VANILLA, XSMALL
• 09321502044073: COCHLEAR NUCLEUS 7 HEADBAND, VANILLA, SMALL
• 09321502044059: COCHLEAR RESEARCH PLATFORM, 1.0
• 09321502044011: COCHLEAR NUCLEUS 7 HEADBAND, GREY, XSMALL
• 09321502044004: COCHLEAR NUCLEUS 7 HEADBAND, BLACK, XSMALL
• 09321502043991: COCHLEAR NUCLEUS 7 HEADBAND, GREY, SMALL
• 09321502043984: COCHLEAR NUCLEUS 7 HEADBAND, BLACK, SMALL
• 09321502046541: COMPACT AQUA+
• 09321502044936: Custom Sound Suite 5.2 (US) - ISO
• 09321502044066: NUCLEUS® CP900 SERIES INTRAOPERATIVE COIL CABLE
• 09321502039420: Nucleus non-magnetic cassette
• 09321502039413: Nucleus Replacement magnet cassette
• 09321502036818: CI612 Cochlear Implant with contour advance electrode
• 09321502036580: CI632 Cochlear Implant with slim modiolar electrode
• 09321502036573: CI622 Cochlear Implant with slim straight electrode
• 09321502050401: CP1000 COIL 5(I) WHITE, 8CM (PACKED)
• 09321502050395: CP1000 COIL 5(I) WHITE, 6CM (PACKED)
• 09321502050388: CP1000 COIL 5(I) SAND, 8CM (PACKED)
• 09321502050371: CP1000 COIL 5(I) SAND, 6CM (PACKED)
• 09321502050364: CP1000 COIL 5(I) GREY, 8CM (PACKED)
• 09321502050357: CP1000 COIL 5(I) GREY, 6CM (PACKED)
• 09321502050340: CP1000 COIL 5(I) BROWN, 8CM (PACKED)
• 09321502050333: CP1000 COIL 5(I) BROWN, 6CM (PACKED)
• 09321502050326: CP1000 COIL 5(I) BLACK, 8CM (PACKED)
• 09321502050319: CP1000 COIL 5(I) BLACK, 6CM (PACKED)
• 09321502050302: CP1000 AQUA + COIL 5(I), 8CM (PACKED)
• 09321502050296: CP1000 AQUA + COIL 5(I), 6CM (PACKED)
• 09321502046442: CP1000 MAGNET (5 (I), WHITE) - SINGLE PACKED
• 09321502046435: CP1000 MAGNET (5 (I), SAND) - SINGLE PACKED
• 09321502046428: CP1000 MAGNET (5 (I), GREY) - SINGLE PACKED
• 09321502046411: CP1000 MAGNET (5 (I), BROWN) - SINGLE PACKED
• 09321502046404: CP1000 MAGNET (5 (I), BLACK) - SINGLE PACKED
• 09321502046497: CP1000 5 (I) MAGNET COVER (WHITE), PACKED
• 09321502046480: CP1000 5 (I) MAGNET COVER (SAND), PACKED
• 09321502046473: CP1000 5 (I) MAGNET COVER (GREY), PACKED
• 09321502046466: CP1000 5 (I) MAGNET COVER (BROWN), PACKED
• 09321502046459: CP1000 5 (I) MAGNET COVER (BLACK), PACKED
• 09321502039543: Cochlear™ USB Power Adaptor
• 09321502035163: Cochlear™ Y Battery Charger
• 09321502035156: Cochlear™ USB Battery Charger
• 09321502046329: CI624 Cochlear Implant with Slim 20 Electrode
• 09321502051439: Baha 5 SuperPower Earhook 2+ (L)
• 09321502051422: Baha 5 SuperPower Earhook 2+ (M)
• 09321502051415: Baha 5 SuperPower Earhook 2+ (S)
• 09321502051408: Baha 5 SuperPower Earhook 2+ (XS)
• 09321502032988: Cochlear™ Remote Control
• 09321502035224: Cochlear™ Koala Clip
• 09321502045063: Osia 2 Sound Processor Kit
• 09321502042970: CP1000 Processing Unit, Black, Gold Detail