| Primary Device ID | 00850001011037 |
| NIH Device Record Key | 2d9c6fb7-4508-4a51-a40f-6bb098781c1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tablo Hemodialysis Concentrate |
| Version Model Number | PN-0000831 |
| Catalog Number | B-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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001011037 [Primary] |
| GS1 | 10850001011034 [Package] Package: Corrugated carton [4 Units] In Commercial Distribution |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2016-01-29 |
| 10850001011058 | Liquid acid concentrate, 45X, 3K, 2.5Ca, 1 U.S. gallon |
| 10850001011041 | Liquid acid concentrate, 45X, 2K, 2.5Ca, 1 U.S. gallon |
| 00850001011037 | Liquid bicarbonate concentrate, 45X, 1 U.S. gallon |
| 00850001011105 | Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon |