| Primary Device ID | 00850001011181 |
| NIH Device Record Key | a5eb5e9a-7243-477e-a90a-984261b5bc17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tablo(R) Disinfectant Straws |
| Version Model Number | PN-0004681 |
| Catalog Number | PN-0004675 |
| Company DUNS | 788744477 |
| Company Name | OUTSET MEDICAL, INC. |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001011174 [Primary] |
| GS1 | 00850001011181 [Package] Contains: 00850001011174 Package: cardboard box [5 Units] In Commercial Distribution |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-11 |
| Device Publish Date | 2020-08-03 |
| 00850001011266 - Tablo(R) Hemodialysis System | 2025-09-29 Tablo Console |
| 00850001011341 - Tablo(R) Hemodialysis System | 2025-09-29 Tablo Console |
| 00850001011358 - Tablo(R) Hemodialysis System | 2025-09-29 Tablo Console |
| 10850001011218 - Tablo(R) Cartridge | 2025-05-14 Tablo X Cartridge with Needleless Infusion Ports |
| 00850001011242 - Tablo(R) Cartridge | 2025-05-14 Tablo X Cartridge with Needleless Infusion Ports |
| 00850001011259 - Tablo(R) Cartridge | 2024-05-29 Tablo X Cartridge, OMM |
| 00850001011297 - TabloCart™ with Prefiltration Drawer | 2024-05-27 Prefiltration Drawer (Packaged), an optional medical device accessory to the Tablo® Hemodialysis System |
| 00850001011303 - TabloCart™ with Prefiltration Drawer | 2024-05-27 Prefiltration Drawer, an optional medical device accessory to the Tablo® Hemodialysis System |