| Primary Device ID | 00810051086515 |
| NIH Device Record Key | 298e5fd0-7e74-4886-852c-9b7ae027e026 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GuruNanda Water Flosser R3100A |
| Version Model Number | R3100A 4.0 |
| Company DUNS | 079671169 |
| Company Name | Gurunanda, LLC |
| 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 | false |
| 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 | 00810051086515 [Primary] |
| EFS | Unit, Oral Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-10 |
| Device Publish Date | 2025-04-02 |
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| 00810051086515 - GuruNanda Water Flosser R3100A | 2025-04-10 Device R3100A 4.0 + 6 CMW Pods |
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| 00810051087055 - GuruNanda Compact Water Flosser, | 2025-04-10 White |
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