FDA UDI
In Commercial Distribution
🇺🇸 United States
B.BRAUN
DI: 04046963563929
·
Model: 4556
·
B. BRAUN MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- B.BRAUN
- Primary DI
- 04046963563929
- Version / Model
- 4556
- Catalog Number
- 4556
- Company Name
- B. BRAUN MEDICAL INC.
- Labeler DUNS
- 002397347
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-08-09
- Public Version
- 4
- Public Version Date
- 2023-09-06
- Public Version Status
- Update
- Public Device Record Key
- 24c490de-a87c-4f2e-8c67-1e9bed5a9686
Device Description
Duosol™ Bicarb 25 Dialysate K4/Ca0 2X5000 mL (4556)
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
- Yes
- 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 |
|---|---|---|---|---|
| KPO | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35849 | Haemodialysis concentrate | A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046963563929 | GS1 | ||||
| Unit of Use | 04046963563912 | GS1 |
Customer Contacts
- Phone
- +1(800)848-2066
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | HCO3- concentration (mEq/L) : 25.000 MEQ | ||
| Device Size Text, specify | Volume : 5000.000 ML | ||
| Device Size Text, specify | K+ concentration (mEq/L) : 4.000 MEQ | ||
| Device Size Text, specify | Ca++ concentration (mEq/L) : 0.000 MEQ |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- DO NOT FREEZE
- Type
- Special Storage Condition, Specify
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- AVOID EXCESSIVE HEAT