AdaptDx Pro USB-C Wall Charger

GUDID 10850006785084

This is a wall charger used with the AdaptDx Pro headset.

MACULOGIX, INC.

Adaptometer

• Primary Device ID: 10850006785084
• NIH Device Record Key: f1411a59-5335-4aea-b987-23a2439c2135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AdaptDx Pro USB-C Wall Charger
• Version Model Number: 10389
• 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: true
• Serial Number: false
• 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	00850006785087 [Primary]
GS1	10850006785084 [Package]; Contains: 00850006785087; 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: 2022-02-04 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: 2022-02-04This is a wall charger used 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