| Primary Device ID | 10850003180325 |
| NIH Device Record Key | f4e63a44-14af-4d7f-bec4-36198796e5d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easy@Home Fuel Cell Breathalyzer |
| Version Model Number | EAT-05FL |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850003180328 [Primary] |
| GS1 | 10850003180325 [Package] Contains: 00850003180328 Package: Carton [40 Units] In Commercial Distribution |
| DJZ | Devices, Breath Trapping, Alcohol |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-08 |
| Device Publish Date | 2019-07-31 |
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