FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782092740
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
5681L-36X7
Catalog number
5681L-36X7
Device description
Adstation Oto+-L,Throat-X, Clock Aner/Spec Disp
Published
2018-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782092740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782092740006347820927406347820927400634782092740

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic/otologic diagnostic setA collection of battery-powered devices intended to be used by a physician to perform an ophthalmic and/or otoscopic clinical examination on a patient. The devices are typically enclosed in a dedicated case and will typically include an ophthalmoscope and an otoscope, a dedicated interchangeable handle that contains the batteries which may be rechargeable and common to these examination devices, spare parts (e.g., extra ear specula, light bulbs) may include a line-powered charging station (e.g., desktop, wall-mounted) to house/charge these devices. This is a reusable device that may contain some disposable devices.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782603045ADC54202542022026-03-31
00634782603052ADC54203542032026-03-31
00634782603069ADC54204542042026-03-31
00634782603076ADC54205542052026-03-31
00634782098384Adscope®603-04W603-04W2026-03-30
00634782100209Adscope®608-12COP608-12COP2026-03-30
00634782100216Adscope®608-12G608-12G2026-03-30
00634782100223Adscope®608-12I608-12I2026-03-30
00634782100230Adscope®608-12ST608-12ST2026-03-30
00634782100247Adscope®608-12MBK608-12MBK2026-03-30
00634782100254Adscope®608-12RGBK608-12RGBK2026-03-30
00634782100261Adscope®608-12RGW608-12RGW2026-03-30
00634782100834Adscope®608-12BK608-12BK2026-03-30
00634782101190Adscope®608-01MBK608-01MBK2026-03-30
00634782101299Adsoft®602-078BK1Q602-078BK1Q2026-03-30
00634782101305Adsoft®602-078PR1Q602-078PR1Q2026-03-30
00634782101312Adsoft®602-078TQ1Q602-078TQ1Q2026-03-30
00634782101329Adsoft®602-078G1Q602-078G1Q2026-03-30
00634782101336Adsoft®602-078Y1Q602-078Y1Q2026-03-30
00634782101343Adsoft®602-078P1Q602-078P1Q2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16972545090024JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-03
06972545090133JeashiaZhejiang Honsun Medical Technology Co., Ltd.HLJ2026-02-02
00732094357929Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-11-25
04053755202966BETA X OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2025-07-17
00732094357936Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
00732094357943Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2025-03-27
10193489136241MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-11-28
10193489136210MEDLINEMEDLINE INDUSTRIES, INC.HLJ2024-09-09
00810149097515R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-08-28
04053755202232K 180 LED OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2024-06-27
00850038195335Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00850038195342Eli EzerU.S. OPHTHALMIC, L.L.C.HLJ2024-04-03
00810149090684R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090745R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149090837R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091056R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149091148R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149092039R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093630R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149093647R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094637R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00810149094644R&D Batteries, Inc.R & D Batteries, Inc.HLJ2024-01-01
00634782601669Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2023-12-15
04030155000392EUROLIGHT E30, 2.5V ophthalmoscope with clic-closureKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscopeKirchner & Wilhelm GmbH + Co KGHLJ2023-09-04
04053755120000BETA 200 S OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755120017K 180 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-15
04053755119981BETA 200 OPHTHALMOSCOPEHeine Optotechnik GmbH & Co. KGHLJ2022-12-12
00733657274714ADSTATION OTO LED/OPH COAX LED W/SPECALIMED, INC.HLJ2022-12-01
00732094347074Welch Allyn, Inc.WELCH ALLYN, INC.HLJ2022-08-05