FDA UDI
In Commercial Distribution
🇺🇸 United States
BICARB, DUAL, 100, MIX/DEL/1000, SP
DI: BC0012
·
Model: EQASSY100BC-1000SP
·
BETTER WATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BICARB, DUAL, 100, MIX/DEL/1000, SP
- Primary DI
- BC0012
- Version / Model
- EQASSY100BC-1000SP
- Catalog Number
- EQASSY100BC-1000SP
- Company Name
- BETTER WATER, LLC
- Labeler DUNS
- 055252159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 4
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 413839d8-b51b-4100-a4fa-795b5a446645
Device Description
Bicarbonate mixer with dual 100 gallon tanks, for central mix and delivery in dialysis applications, with large pump for longer loops. Short profile height.
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 |
|---|---|---|---|---|
| FIN | Tank, Holding, Dialysis | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36345 | Haemodialysis bicarbonate solution preparation mixer | An electrically-powered unit intended to mix a bicarbonate concentrate(s), commonly in powder form, with water to produce a bicarbonate haemodialysis solution. It typically includes tanks with connection hoses, controls and display; some types may include solution delivery features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | BC0012 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992793 | 000 |