| Primary Device ID | 00850001011013 |
| NIH Device Record Key | bf24d426-f8ad-4465-abec-5b14d3ebb89e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tablo Cartridge |
| Version Model Number | DWG-3008 |
| Catalog Number | CART-100 |
| 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 | 00850001011013 [Primary] |
| GS1 | 10850001011010 [Package] Package: Carton [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 | 5 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2015-10-23 |
| 10850001011072 | Tablo Cartridge with Needleless Infusion Ports |
| 00850001011013 | DWG-3008 |