AdaptDx

GUDID 00850006785001

AdaptDx Dark Adaptometer Model Dx-04; tabletop device used to measure dark adaptation.

MACULOGIX, INC.

Adaptometer

• Primary Device ID: 00850006785001
• NIH Device Record Key: 09859ecd-6425-421e-bd18-64ba004423cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdaptDx
• Version Model Number: Dx-04
• Company DUNS: 962692179
• Company Name: MACULOGIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006785001 [Primary]
GS1	10850006785008 [Package]; Package: Shipping Box [1 Units]; In Commercial Distribution

FDA Product Code

• OUM: Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-04
• Device Publish Date: 2022-01-27

Devices Manufactured by MACULOGIX, INC.

• 00850006785001 - AdaptDx: 2022-02-04AdaptDx Dark Adaptometer Model Dx-04; tabletop device used to measure dark adaptation.
• 00850006785001 - AdaptDx: 2022-02-04 AdaptDx Dark Adaptometer Model Dx-04; tabletop device used to measure dark adaptation.
• 10850006785077 - AdaptDx Pro USB-C Headset Cable: 2022-02-04 This is a USB-C cable used to connect the AdaptDx Pro handheld controller with the AdaptDx Pro headset.
• 10850006785084 - AdaptDx Pro USB-C Wall Charger: 2022-02-04 This is a wall charger used with the AdaptDx Pro headset.
• 00850006785100 - AdaptDx Pro International: 2022-02-04 Wearable dark adaptometer heasdset
• 00850006785025 - AdaptDx Pro USB-C Wall Charger International: 2022-02-03 This is an international wall charger used with the AdaptDx Pro headset.
• 10850006785039 - AdaptDx Pro Handheld Controller: 2021-12-14 Handheld controller for the AdaptDx Pro
• 10850006785015 - AdapDx Pro: 2021-04-19 A headset that is used to measure dark adaptation.
• 10850006785053 - AdaptDx Pro Head Strap liner: 2021-04-19 Head strap liner for the AdaptDx Pro