FDA.reportPublic FDA data

Children's Battery Pack blue 27 cm

Primary DI
09008737039387
Brand
Children's Battery Pack blue 27 cm
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
03938
Device description
Audio Processor Battery Pack
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MCMImplant, Cochlear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P000025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P000025000COMBI 40+ COCHLEAR IMPLANT SYSTEMMed-El Corp.2001-08-20MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737039387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737039387090087370393879008737039387

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant systemA battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Dedicated implantation instruments may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)633-3524implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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09008737346911ADHEAR Headband, black346912018-06-27
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09008737353254ADHEAR Headband, pink353252018-06-27
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09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
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Primary DI, Brand, Company table
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09008737461416SONNET Battery Pack Cover Standard Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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09008737461522SONNET Battery Pack Cover Micro Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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