Cochlear P1659648
GUDID 09321502050395
CP1000 COIL 5(I) WHITE, 6CM (PACKED)
COCHLEAR LIMITED
Cochlear implant system coil| Primary Device ID | 09321502050395 |
| NIH Device Record Key | 2233894d-afb9-4911-9f26-86c90f276bc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cochlear |
| Version Model Number | P1659648 |
| Catalog Number | P1659648 |
| Company DUNS | 750551194 |
| Company Name | COCHLEAR LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502050395 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970051
FDA Product Code
| MCM | Implant, cochlear |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-26 |
| Device Publish Date | 2019-11-18 |
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 |
Trademark Results [Cochlear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COCHLEAR 79308437 not registered Live/Pending |
Cochlear Limited 2021-02-17 |
 COCHLEAR 79302761 not registered Live/Pending |
Cochlear Limited 2020-12-11 |
 COCHLEAR 79226500 5682597 Live/Registered |
Cochlear Limited 2017-11-30 |
 COCHLEAR 79106109 4615507 Live/Registered |
Cochlear Limited 2011-06-30 |
 COCHLEAR 76656230 3390528 Live/Registered |
COCHLEAR LIMITED 2006-03-03 |
 COCHLEAR 76608815 3175621 Live/Registered |
Cochlear Limited 2004-08-26 |
 COCHLEAR 76583999 3502096 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583996 3502095 Dead/Cancelled |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583995 3200044 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583960 3767745 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 74278522 1764350 Dead/Cancelled |
Cochlear Pty. Limited 1992-05-22 |
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