| Primary Device ID | 00048582004405 |
| NIH Device Record Key | db36d159-ae25-4f1b-b746-b0bccd930ff8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotene Oral Rinse Dry Mouth |
| Version Model Number | 1 |
| Company DUNS | 079944263 |
| Company Name | Glaxosmithkline Consumer Healthcare Holdings (us) LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | 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 | 00048582004405 [Primary] |
| LFD | Saliva, Artificial |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-11 |
| Device Publish Date | 2023-04-03 |
| 00048582001558 - Biotene | 2023-04-24 Biotene Mouth Spray 1.5 oz |
| 00048582003309 - Biotene | 2023-04-24 Biotene Dry Mouth Oral Rinse 16 oz |
| 00048582004566 - Biotene | 2023-04-24 Biotene Dry Mouth Gentle Oral Rinse 16 oz |
| 00048582004580 - Biotene | 2023-04-24 Biotene Dry Mouth Gentle Oral Rinse 33.8 oz |
| 00048582100077 - Biotene | 2023-04-24 Biotene Dry Mouth Sample 15 mL |
| 00048582120266 - Biotene | 2023-04-24 Biotene Ecommerce Variety Pack Rinse Spray |
| 00048582285422 - Biotene | 2023-04-24 Biotene Oral Rinse 33.8 oz Twin Pack |
| 00048582350410 - Biotene | 2023-04-24 Biotene Oral Rinse Twin Pack 2x33.8 oz |