| Primary Device ID | 10840861102409 |
| NIH Device Record Key | ad74aef8-6d08-4144-9dce-2d759844dff1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CombiSet |
| Version Model Number | 03-2522-1 |
| Catalog Number | 03-2522-1 |
| 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 | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx | |
| Phone | 800-323-5188 |
| xx@xx.xx |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from moisture, freezing, and excessive heat |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840861102402 [Primary] |
| GS1 | 10840861102409 [Package] Contains: 00840861102402 Package: [28 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-27 |
| Device Publish Date | 2023-10-19 |
| 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 |