FDA UDI
In Commercial Distribution
🇺🇸 United States
CATSmart
DI: 04086000860048
·
Model: 9005901
·
Fresenius Kabi AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CATSmart
- Primary DI
- 04086000860048
- Version / Model
- 9005901
- Catalog Number
- 9005901
- Company Name
- Fresenius Kabi AG
- Labeler DUNS
- 315654579
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-26
- Public Version
- 6
- Public Version Date
- 2023-06-22
- Public Version Status
- Update
- Public Device Record Key
- 8d088e78-74c9-4591-a7f2-805a2295d824
Device Description
The CATSmart (Continuous Autotransfusion System) by Fresenius is indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 868.5830 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66789 | Autotransfusion system blood collection/processing pump | An electrically-powered device intended to be used in conjunction with a collection of appropriate containers and tubing (not included) to produce pressure for the collection of blood from a patient and the subsequent processing (filter/wash) of the blood components (e.g., red or white blood cells, platelets) as part of an autotransfusion procedure. It typically incorporates a peristaltic and aspiration (suction) pump. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04086000860048 | GS1 |
Customer Contacts
- Phone
- +4961726868436
- [email protected]