| Primary Device ID | 10855944007243 |
| NIH Device Record Key | 24b4161e-92d2-4ac0-b5e7-31c9c3d0679c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easy@Home Pregnancy Test (3 HCG Midstreams) |
| Version Model Number | EZW1-M |
| Catalog Number | EZM1-H3 |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00855944007246 [Primary] |
| GS1 | 10855944007243 [Package] Contains: 00855944007246 Package: Carton [84 Units] In Commercial Distribution |
| GS1 | 20855944007240 [Package] Contains: 00855944007246 Package: Carton [70 Units] In Commercial Distribution |
| GS1 | 30855944007247 [Unit of Use] |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-01 |
| Device Publish Date | 2018-07-01 |