FDA UDI
In Commercial Distribution
🇺🇸 United States
Hemodialysis Delivery System
DI: 04987671041708
·
Model: DBB-06 PRO
·
NIKKISO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hemodialysis Delivery System
- Primary DI
- 04987671041708
- Version / Model
- DBB-06 PRO
- Company Name
- NIKKISO CO.,LTD.
- Labeler DUNS
- 690542378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-22
- Public Version
- 2
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- f70d5967-6080-4147-a98d-f82791a8da1b
Device Description
The DBB-06 PRO Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. The DBB-06 PRO Hemodialysis Delivery System is not indicated for pediatric patients. It is not for home use.
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 |
|---|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Gastroenterology, Urology | 876.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34994 | Haemodialysis system dialysate delivery unit | An electrically-powered integral unit of a haemodialysis system that prepare and delivers the haemodialysis dialysate solution to the haemodialysis dialyser where it is used in the treatment of the patient (one patient only). It monitors and controls such indicators as temperature, conductivity, flow rate, and pressure. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 24987671041702 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 04987671041708 | GS1 |
Customer Contacts
- Phone
- +81334433727
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 95 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Disinfect and drain before storing. Store upright in a well-ventilated room with minimal temperature fluctuations. Charge the battery every six months and after each storage period.