| Primary Device ID | 10810038634293 |
| NIH Device Record Key | 7ebaba26-70dc-4f8f-9498-53790412f330 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easy@Home Ovulation Test (50 LH strips+50 Cups) |
| Version Model Number | EZW2-S |
| Catalog Number | EZW-LH50C50 |
| Company DUNS | 080278407 |
| Company Name | EASY HEALTHCARE CORPORATION |
| Device Count | 50 |
| 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 | 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 | 00810038634296 [Primary] |
| GS1 | 10810038634293 [Package] Contains: 00810038634296 Package: Carton [45 Units] In Commercial Distribution |
| GS1 | 30810038634297 [Unit of Use] |
| NGE | Test, Luteinizing Hormone (Lh), 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 | 2023-04-20 |
| Device Publish Date | 2023-04-12 |
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