CATSmart 9005901
GUDID 04086000860048
The CATSmart (Continuous Autotransfusion System) by Fresenius is indicated for the processing of autologous shed blood collected intraoperatively and
Fresenius Kabi AG
Blood-processing autotransfusion system| Primary Device ID | 04086000860048 |
| NIH Device Record Key | 8d088e78-74c9-4591-a7f2-805a2295d824 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CATSmart |
| Version Model Number | 9005901 |
| Catalog Number | 9005901 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04086000860048 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160735
FDA Product Code
| CAC | Apparatus, Autotransfusion |
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 | 2016-09-26 |
Devices Manufactured by Fresenius Kabi AG
| 00810020441062 - Fenwal Hand Sealer | 2025-05-08 The Hand Sealer is used to provide a hermetic closure on Blood-Pack Unit tubings when used with the Fenwal Hand Sealer Clips, co |
| 10810020441748 - Adaptive Nomogram Bottle | 2025-03-24 For the collection, storage, and shipment of plasma prior to fractionation. For the collection of blood components. Sterile flui |
| 00810020440560 - Aurora Xi | 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.1 |
| 00810020442199 - Aurora Xi | 2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.0 |
| 10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter | 2025-01-23 For the collection of blood components. Sterile Fluid Path |
| 10810020440512 - Adaptive Nomogram Transfer Pack | 2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path |
| 00811505030450 - Ivenix Infusion System | 2024-12-16 Infusion Management System (IMS) |
| 00811505030467 - Ivenix Infusion System | 2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump) |
Trademark Results [CATSmart]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATSMART 87111294 5297831 Live/Registered |
Fresenius Kabi AG 2016-07-21 |
 CATSMART 87111292 5307811 Live/Registered |
Fresenius Kabi AG 2016-07-21 |
 CATSMART 79325454 not registered Live/Pending |
Olivier PONCIN 2021-09-20 |
 CATSMART 77216951 not registered Dead/Abandoned |
Asia Interpacific, Inc. 2007-06-27 |
 CATSMART 77216949 not registered Dead/Abandoned |
Asia Interpacific, Inc. 2007-06-27 |
 CATSMART 77216945 not registered Dead/Abandoned |
Asia Interpacific, Inc. 2007-06-27 |
 CATSMART 75211261 2246451 Dead/Cancelled |
Isadra, Inc. 1996-12-10 |
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