Cochlear

Primary DI
09321502034449
Brand
Cochlear
Company
Cochlear Bone Anchored Solutions AB
Model
P770844
Catalog number
P770844
Device description
Cochlear Wireless Mini Microphone 2 US
Published
2017-04-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09321502034449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09321502034449093215020344499321502034449

GMDN Terms

TermDefinition
Hearing aid enhanced audio device, telecommunication/multimediaA battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the sound quality received by the wearer of the hearing aid. It is typically a hand-held electronic unit, portable or placed in the home, intended to provide features such as artefact-free, echo-free, real-time audio transmission in and sometimes to remotely manage selected features in the hearing aid or external audio source for improved sound quality.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags

DUNS number
559784736
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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