FDA UDI
In Commercial Distribution
🇺🇸 United States
DIASOL
DI: B467CC63
·
Model: CC6.3
·
DIASOL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DIASOL
- Primary DI
- B467CC63
- Version / Model
- CC6.3
- Catalog Number
- CC4
- Company Name
- DIASOL, INC.
- Labeler DUNS
- 068434658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-04-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6706e645-07cb-4208-bbb3-f461cad846be
Device Description
Dialysate Additive 6.3 grams Calcium Chloride to increase Calcium by 0.5mEq/L when added to 3.785 liters of concentrate proportioned at 1:44
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | B467CC63170 | HIBCC | CASE | 170 | In Commercial Distribution | |
| Primary | B467CC63 | HIBCC |
Customer Contacts
- Phone
- 818-838-7077
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020231 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 6.3 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature