| Primary Device ID | 10840861100337 |
| NIH Device Record Key | dfa1938b-6959-4afd-bba1-3e4ba2217ab2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CombiSet |
| Version Model Number | 03-2962-3 |
| Catalog Number | 03-2962-3 |
| Company DUNS | 958291411 |
| Company Name | Fresenius Medical Care Holdings, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)323-5188 |
| xxx@xxx.xxx |
| Total Volume | 134 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861100330 [Primary] |
| GS1 | 10840861100337 [Package] Contains: 00840861100330 Package: [24 Units] In Commercial Distribution |
| ONW | Hemodialysis system for home use |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2015-09-24 |
| 10840861100474 | Pre-pump, 8.0 mm, BVM |
| 10840861100337 | Pre-pump, 8.0 mm, Home Hemo with prime bag |
| 10840861100320 | Pre-pump, 8.0 mm |
| 10840861100306 | Pre-pump, 8.0 mm |
| 10840861100290 | Pre-pump, 8.0 mm |
| 10840861100283 | 8.0 mm, single needle |
| 10840861100269 | Pre-pump, 6.35 mm, low volume |
| 10840861100252 | Post-pump, 6.35 mm |
| 10840861100245 | Pre-pump, 6.35 mm |
| 10840861100238 | Pre-pump, 8.0 mm |
| 10840861100221 | Post-pump, 8.0 mm |
| 10840861102409 | 03-2522-1 |