| Primary Device ID | 10840861100313 |
| NIH Device Record Key | 3dfa9781-f532-40b1-8770-a70c8ada49d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CombiSet Twister |
| Version Model Number | 03-2794-0 |
| Catalog Number | 03-2794-0 |
| 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 | 142 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861100316 [Primary] |
| GS1 | 10840861100313 [Package] Contains: 00840861100316 Package: [24 Units] In Commercial Distribution |
| KOC | ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS |
| 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 |
| 20840861100549 - Fresenius | 2025-08-07 Transducer Protectors, bulk pack |
| 10840861102638 - FX CorAL 60 Dialyzer | 2024-03-04 |
| 10840861102652 - FX CorAL 100 Dialyzer | 2024-03-04 |
| 10840861102669 - FX CorAL 120 Dialyzer | 2024-03-04 |
| 10840861102676 - FX CorAL 600 Dialyzer | 2024-03-04 |
| 10840861102683 - FX CorAL 800 Dialyzer | 2024-03-04 |
| 10840861102690 - FX CorAL 1000 Dialyzer | 2024-03-04 |
| 10840861102409 - CombiSet | 2023-10-27 |