Libby Horn

Primary DI
E23903211
Brand
Libby Horn
Company
Dreve Otoplastik GmbH
Model
0321
Catalog number
0321
Device description
No.
Published
2022-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing aid, air conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E23903211PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid acoustic tubeA small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+49230388070otoplastik@dreve.de

Regulatory Flags#

DUNS number
315808340
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
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06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126190000AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190017AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190024AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190031AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
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00810126190055AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190086AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190116AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190161AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190178AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190185AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190192AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26