| Primary Device ID | B268Y7057A51 |
| NIH Device Record Key | f8bf92ac-7069-408f-9e38-86f980ca365f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The First Years |
| Version Model Number | Y7057A5 |
| Catalog Number | Y7057A5 |
| Company DUNS | 065183758 |
| Company Name | TOMY INTERNATIONAL, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
|---|---|
| HIBCC | B268Y7057A51 [Primary] |
| HIBCC | B268Y7057A53 [Package] Package: Inner Carton [3 Units] In Commercial Distribution |
| HIBCC | B268Y7057A59 [Package] Contains: B268Y7057A53 Package: Master Carton [12 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-22 |
| Device Publish Date | 2024-01-12 |
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| B268Y60531 | Quiet Expressions Plus Rechargeable Pump - Double |
| B268Y52880 | Star Teether |
| B268Y7078A61 | Digital Thermometer |
| B268Y7057A51 | Health and Grooming Kit |
| B268Y79571 | Health and Grooming Kit |
| B268Y7078A71 | Multi-Use Digital Thermometer |
| B268Y7078A81 | Multi-Use Digital Thermometer |