FDA UDI
In Commercial Distribution
🇺🇸 United States
2008® Series Hemodialysis Machines
DI: 00840861100941
·
Model: 190828
·
Fresenius Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 2008® Series Hemodialysis Machines
- Primary DI
- 00840861100941
- Version / Model
- 190828
- Company Name
- Fresenius Usa, Inc.
- Labeler DUNS
- 076594100
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2020-09-28
- Public Version Status
- Update
- Public Device Record Key
- ba624e74-0747-4a83-b6e1-3640f558bc29
Device Description
2008K@HOME HEMODIALYSIS SYSTEM
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
- No
- 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 |
|---|---|---|---|---|
| ONW | Hemodialysis system for home use | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58131 | Haemodialysis system, institutional/home-use | An assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840861100941 | GS1 |
Customer Contacts
- Phone
- +1(800)227-2572
- [email protected]