FDA.reportPublic FDA data

AdapDx Pro

Primary DI
00850006785018
Brand
AdapDx Pro
Company
MACULOGIX, INC.
Model
M-1
Device description
A headset that is used to measure dark adaptation.
Published
2021-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus GenerationOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850006785015PackageGS11In Commercial Distribution
20850006785012PackageGS11In Commercial Distribution
00850006785018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000678501510850006785015
2085000678501220850006785012
00850006785018008500067850188500067850180850006785018

GMDN Terms#

Term, Definition table
TermDefinition
AdaptometerA mains electricity (AC-powered) ophthalmic device that provides a stimulating light source having various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.

Regulatory Flags#

DUNS number
962692179
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006785070AdaptDx Pro USB-C Headset Cable103882022-01-27
00850006785087AdaptDx Pro USB-C Wall Charger103892022-01-27
00850006785001AdaptDxDx-042022-01-27
10850006785077AdaptDx Pro USB-C Headset Cable103882022-01-27
10850006785084AdaptDx Pro USB-C Wall Charger103892022-01-27
00850006785100AdaptDx Pro International103902022-01-27
00850006785025AdaptDx Pro USB-C Wall Charger International108702022-01-26
00850006785032AdaptDx Pro Handheld ControllerHC-12021-04-09
00850006785056AdaptDx Pro Head Strap liner101452021-04-09
00850006785063AdaptDx Pro Head StrapHS-12021-04-09
10850006785039AdaptDx Pro Handheld ControllerHC-12021-04-09
00850006785049AdaptDx Pro Eye Cups103192021-04-09
10850006785015AdapDx ProM-12021-04-09
10850006785053AdaptDx Pro Head Strap liner101452021-04-09
10850006785060AdaptDx Pro Head StrapHS-12021-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014752704TwilightEVOQ TECHNOLOGIES CORP.OUM2025-12-30
G506MACDX010MacDxAMA Optics, Inc.OUM2023-09-01
00850006785070AdaptDx Pro USB-C Headset CableMACULOGIX, INC.OUM2022-01-27
00850006785087AdaptDx Pro USB-C Wall ChargerMACULOGIX, INC.OUM2022-01-27
00850006785001AdaptDxMACULOGIX, INC.OUM2022-01-27
10850006785077AdaptDx Pro USB-C Headset CableMACULOGIX, INC.OUM2022-01-27
10850006785084AdaptDx Pro USB-C Wall ChargerMACULOGIX, INC.OUM2022-01-27
00850006785100AdaptDx Pro InternationalMACULOGIX, INC.OUM2022-01-27
00850006785025AdaptDx Pro USB-C Wall Charger InternationalMACULOGIX, INC.OUM2022-01-26
00850006785032AdaptDx Pro Handheld ControllerMACULOGIX, INC.OUM2021-04-09
00850006785056AdaptDx Pro Head Strap linerMACULOGIX, INC.OUM2021-04-09
00850006785063AdaptDx Pro Head StrapMACULOGIX, INC.OUM2021-04-09
10850006785039AdaptDx Pro Handheld ControllerMACULOGIX, INC.OUM2021-04-09
10850006785015AdapDx ProMACULOGIX, INC.OUM2021-04-09
10850006785053AdaptDx Pro Head Strap linerMACULOGIX, INC.OUM2021-04-09
10850006785060AdaptDx Pro Head StrapMACULOGIX, INC.OUM2021-04-09