Home GUDID 04048551054079 n.a.
Primary DI 04048551054079
Brand n.a.
Company Karl Storz GmbH & Co. KG
Model 1228D
Device description Rubber Tip for pneumatic testing
Published 2018-09-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ERA OTOSCOPE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ERA Otoscope Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04048551054079 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04048551054079 04048551054079 4048551054079
GMDN Terms# Term, Definition table Term Definition Middle ear decompressor, positive pressure A manual device intended to reduce the symptoms associated with negative air pressure in the middle ear by increasing air pressure in the Eustachian tube, to counter/prevent certain physical states or thick fluid accumulation behind the eardrum. It typically consists of a manually-operated deflator/inflator (e.g., balloon) connected to an applicator (e.g., nosepiece, mouthpiece, face mask). This is a reusable device typically used in the home.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 315731430 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05713315012341 Aurical Otocam 300-III Natus Medical Denmark ApS ERA 2026-07-20 06972545090485 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-07-17 16972545090154 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-07-17 04260154547271 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547400 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547417 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547424 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547448 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547455 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547462 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547479 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547486 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547493 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 04260154547530 OTOPRONT Happersberger Otopront GmbH ERA 2026-07-08 16972545090017 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 16972545090031 Jeashia Zhejiang Honsun Medical Technology Co., Ltd. ERA 2026-05-18 00050428029497 CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED ERA 2026-02-13 KTS0025716 K.T.Surgico K.T.SURGICO ERA 2024-07-24 00311917035000 Walgreens WALGREEN CO. ERA 2023-11-01 20884392954455 Safety 1st DOREL JUVENILE GROUP, INC. ERA 2023-10-15 10884389104514 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 10884389104521 Medline MEDLINE INDUSTRIES, INC. ERA 2023-01-21 17290018446154 Nonagon N9+ NONAGON LTD ERA 2022-09-28 27290018446151 Nonagon N9+ SmartExam NONAGON LTD ERA 2022-09-28 00860003469828 hearX HEARX GROUP (PTY) LTD ERA 2022-05-30 M368122711 LABTRON GF HEALTH PRODUCTS, INC. ERA 2020-09-15 H65811255271 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 H65811255281 Henry Schein HENRY SCHEIN, INC. ERA 2020-06-16 10304040029203 Henry Schein HENRY SCHEIN, INC. ERA 2018-12-21 10304040029197 Henry Schein HENRY SCHEIN, INC. ERA 2018-09-24