COM.TEC 9008031
GUDID 04086000860154
The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are
Fresenius Kabi AG
Apheresis system| Primary Device ID | 04086000860154 |
| NIH Device Record Key | 93626510-b09e-4cd8-a8cc-58df845ce1dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COM.TEC |
| Version Model Number | 9008031 |
| Catalog Number | 9008031 |
| Company DUNS | 315654579 |
| Company Name | Fresenius Kabi AG |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4916726868436 |
| dieter.fries@fresenius-kabi.co |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000860154 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060734
FDA Product Code
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-03 |
| Device Publish Date | 2016-09-16 |
Devices Manufactured by Fresenius Kabi AG
| 00810020440591 - AMICUS Separator Legacy Software | 2024-04-04 Software version for AMICUS Separator Legacy Device |
| 00810020440607 - AMICUS Separator Life Extension Software | 2024-04-04 Software version for AMICUS Separator Life Extension Device |
| 04250273750164 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750218 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750287 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 04250273750294 - Volumat™ Line | 2024-03-29 IV administration set for infusion pumps |
| 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual | 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol |
| 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual | 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F |
Trademark Results [COM.TEC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COM.TEC 75898494 2647841 Live/Registered |
Fresenius Hemocare GmbH 2000-01-18 |
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