FDA UDI
In Commercial Distribution
🇺🇸 United States
HEMODIALYSIS DELIVERY SYSTEM
DI: 04987671060006
·
Model: DBB-06
·
NIKKISO CO.,LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HEMODIALYSIS DELIVERY SYSTEM
- Primary DI
- 04987671060006
- Version / Model
- DBB-06
- Company Name
- NIKKISO CO.,LTD.
- Labeler DUNS
- 690542378
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-12
- Public Version
- 4
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- f20b6d6b-36f8-42ae-b9bb-fb59a9a0bd31
Device Description
The DBB-06 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 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04987671060006 | GS1 |
Customer Contacts
- Phone
- +81334433727
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152938 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Must be disinfected and drained before storing. Store upright in a well-ventilated room with minimal temperature fluctuation. The battery used must be charged every time after storage.
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal