FDA UDI
In Commercial Distribution
🇺🇸 United States
Blood Circuit Set
DI: 10853072007005
·
Model: UF 500
·
Nuwellis Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Blood Circuit Set
- Primary DI
- 10853072007005
- Version / Model
- UF 500
- Catalog Number
- 114157
- Company Name
- Nuwellis Inc.
- Labeler DUNS
- 790580182
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-22
- Public Version
- 4
- Public Version Date
- 2021-11-25
- Public Version Status
- Update
- Public Device Record Key
- 5ab81bc8-9681-4b1b-9c53-aaab029205bb
Device Description
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44601 | Haemofilter | A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10853072007005 | GS1 | ||||
| Package | 30853072007016 | GS1 | Box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-855-786-2778
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius