| Primary Device ID | D79011549033 |
| NIH Device Record Key | 03f73fbc-7c3e-48b3-b366-3a1e4807b022 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PureLife Dental |
| Version Model Number | 1154903 |
| Catalog Number | 1154903 |
| Company DUNS | 828690904 |
| Company Name | PURELIFE, LLC |
| Device Count | 50 |
| 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 | true |
| Lot Batch | true |
| 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 |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D79011549030 [Unit of Use] |
| HIBCC | D79011549031 [Primary] |
| HIBCC | D79011549033 [Package] Contains: D79011549031 Package: Case [500 Units] In Commercial Distribution |
| FXX | Mask, surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-16 |
| Device Publish Date | 2025-07-08 |
| D79011901053 | 5 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indica |
| D79011901043 | 3 1/2" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat |
| D79011901033 | 3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process ind |
| D79011901023 | 2 3/4" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicat |
| D79011901013 | 2 1/4" x 4" Sterilization Pouches, Built-in color-changing internal and external process indicat |
| D79011501023 | Pink Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex |
| D79011501013 | Blue Earloop Face Masks, ASTM Level 1: BFE >= 95%, Inner and outer fluid-resistant layers, Latex |
| D79011103020 | 4" x 4" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting |
| D79011103010 | 2" x 2" Non-Woven Sponges, High-quality 4-ply sponges, Non-linting |
| D79010811040 | Lilac "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock |
| D79010811030 | Pink "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock |
| D79010811020 | Blue "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock |
| D79010811010 | White "B" Ritter Tray Covers, 8 1/2" x 12 1/4", Made with high-quality paper stock |
| D79011549023 | PureLife Level 3 Masks Pink |
| D79011549013 | PureLife Level 3 Masks Blue |
| D79011430023 | Clear/Blue Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient comf |
| D79011430013 | White/White Saliva Ejectors, Phthalates-free, Flexible with smooth edges for maximum patient com |
| D79011549033 | PureLife ASTM Level 3 Earloop Face Masks, Lavender, ASTM Level 3: BFE >= 98%, Fluid-resistant, L |