FDA.reportPublic FDA data

zumax

Primary DI
06945095521006
Brand
zumax
Company
Zumax Medical Co., LTD
Model
OT8
Device description
3.5V Otoscope
Published
2018-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095521006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095521006069450955210066945095521006

GMDN Terms#

Term, Definition table
TermDefinition
Audiometer/otoscopeA battery-powered, hand-held device intended for: 1) visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening; and 2) evaluation of hearing by generating tones throughout the audible range (usually at each octave between 125 Hz and 8 kHz) at amplitudes related to the expected thresholds for a normally hearing person, and presenting them to a patient (pure-tone audiometery). It consists of a handle that contains the batteries (which may be rechargeable), a built-in light to illuminate the ear canal, a pitch generator (speaker), and is intended to be used with a detachable ear speculum which may be included. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421348837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095527749zumaxOMS3200228V3742-292026-07-06
06945095527756zumaxOMS3200228V3740-292026-07-06
06945095527763zumaxOMS3000 Pro820110-10152-0002026-07-06
06945095527787zumaxOMS3500237-04102026-07-06
06945095527794zumaxOMS2380820110-10154-0002026-07-06
06945095527817zumaxOMS3500820111-10105-0002026-07-06
06945095527848zumaxOMS2350230V0041-002026-07-06
06945095527879zumaxOMS3500 Max820111-10107-0002026-07-06
06945095527886zumaxOMS2350230-0047-002026-07-06
06945095527893zumaxOMS3500820111-10109-0002026-07-06
06945095527909zumaxOMS2050252V0742-R5-282026-07-06
06945095527916zumaxOMS2380283V2850-002026-07-06
06945095527954zumaxOMS3200832100053762-292026-07-06
06945095528005zumaxOMS3200Pro323V3842-002026-07-06
06945095528012zumaxOMS3200Pro323V375N-002026-07-06
06945095528029zumaxOMS2380820110-10169-0002026-07-06
06945095528036zumaxOMS3200321V0041-002026-07-06
06945095528043zumaxOMS2380820110-10171-0002026-07-06
06945095528050zumaxOMS3000 Pro227V374N-002026-07-06
06945095528067zumaxOMS3200Pro323V37602026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21