FDA.reportPublic FDA data

Diagnostix™

Primary DI
00634782588366
Brand
Diagnostix™
Company
AMERICAN DIAGNOSTIC CORP
Model
5110NLV
Catalog number
5110NLV
Device description
DIAGNOSTIX Pocket Oto/Opht Set,2.5v, LED, Purple
Published
2017-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093495000OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITSAmerican Diagnostic Corp.2010-11-19HLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782588366PackageGS14In Commercial Distribution
00634782086930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782588366006347825883666347825883660634782588366
00634782086930006347820869306347820869300634782086930

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 Temperature-4 Degrees Fahrenheit120.2 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
M368122731LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
M368122741LabtronGF HEALTH PRODUCTS, INC.HLJ2020-09-22
00192896009509HEINE - BETA R HANDLESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009516HEINE - LITHIUM ION BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009523HEINE MPACK MINI SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009530HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009547HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009554HEINE MPACK UNPLUGGED BATTERYSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009561HEINE HC 50 CONNECTING CORDSONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009578HEINE MPACK SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009585HEINE MPACK COMPLETESONTEC INSTRUMENTS, INC.HLJ2018-08-24
00192896009592HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC.HLJ2018-08-24
00634782089221Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089238Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089252Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089276Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089290Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089313Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782089320Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-19
00634782088910Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088934Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088941Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088958Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088965Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088972Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088989Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782088996Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087753Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087760Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12
00634782087784Diagnostix™AMERICAN DIAGNOSTIC CORPHLJ2018-01-12