Libby Horn

Primary DI
E239032101
Brand
Libby Horn
Company
Dreve Otoplastik GmbH
Model
03210
Catalog number
03210
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
E239032101PrimaryHIBCC0

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E23903211Libby Horn032103212022-08-12
E239031501Libby Horn03150031502022-08-12
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E239905001FotoTec® DLP.C90500905002026-01-30
E239361001FotoTec® DLP.B36100361002022-09-15
E239906001FotoTec® DLP.C90600906002026-01-15
E2390871SK 87 Silicone glue0870872022-08-12
E239903001FotoTec® DLP.C90300903002025-07-09
E239908001FotoTec® DLP.C90800908002025-07-09
E2399095011FotoTec® DLP.C9095019095012025-07-09
E239901001FotoTec® DLP.C90100901002025-04-02
E23942511Biopor® UV-S425142512023-10-11
E2392936M1Otoform® A flex2936M2936M2025-01-20
E2392956M1Otoform® A softX2956M2956M2025-01-20
E2393206M1Otoform® A soft3206M3206M2025-01-20
E23904171101Pre-bent tubing041711004171102025-01-13
E23904171501Pre-bent tubing041715004171502025-01-13
E239042501Pre-bent tubing04250042502025-01-13
E23911311Silicone tubing113111312025-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201657AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
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
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191526AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191533AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191540AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191557AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191564AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191571AudinaAudina Hearing Instruments, Inc.ESD2023-01-31