| Primary Device ID | 00850001011143 |
| NIH Device Record Key | f0707176-fec2-40d5-83f8-83f26ec7c49c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tablo(R) Cartridge |
| Version Model Number | PN-0004221 |
| Catalog Number | CART-301 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 844.698.2256 |
| TechnicalService@outsetmedical.com |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001011143 [Primary] |
| GS1 | 10850001011140 [Package] Package: Case [6 Units] In Commercial Distribution |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-01-11 |
| 00850001011143 | The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to pr |
| 00850001011273 | Tablo Cartridge, Needleless, X, with Formula Organizer |
| 00850001011259 | Tablo X Cartridge, OMM |