| Primary Device ID | 10850006785039 |
| NIH Device Record Key | 57f078d3-e605-454e-8f43-82fbb2fa6078 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AdaptDx Pro Handheld Controller |
| Version Model Number | HC-1 |
| Company DUNS | 962692179 |
| Company Name | MACULOGIX, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850006785032 [Primary] |
| GS1 | 10850006785039 [Package] Contains: 00850006785032 Package: Asthetic Box [1 Units] In Commercial Distribution |
| GS1 | 20850006785036 [Package] Package: Shipping Box [1 Units] In Commercial Distribution |
| OUM | Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-12-14 |
| Device Publish Date | 2021-04-09 |
| 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 | 2021-12-14Handheld controller for the AdaptDx Pro |
| 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 |