Identity
- Trade Name
- BICARB, SINGLE, 60, MIX-ONLY FDA UDI
- Generic Name
- Haemodialysis bicarbonate solution preparation mixer FDA UDI
- Device Name
- Bicarbonate mixer with a single 60 gallon tank for mixing only (no delivery) in dialysis applications. FDA UDI
- Model / Reference
- EQASSY60BICARB FDA UDI
- Description
- Bicarbonate mixer with a single 60 gallon tank for mixing only (no delivery) in dialysis applications. FDA UDI
Identifiers
- Catalog Number
- EQASSY60BICARB FDA UDI
- Primary DI / UDI-DI
- BC0302 FDA UDI
- 510(k) Number
- K992793 FDA UDI
- FDA Product Code
- FIN FDA UDI
- GMDN Term
- Haemodialysis bicarbonate solution preparation mixer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemodialysis bicarbonate solution preparation mixer
Bicarb, Single, 60, Mix-Only by Better Water, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis bicarbonate solution preparation mixer.
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Cleared under the same submission
K992793 also covers:
- BICARB, DUAL 60, MIX/DELV — Better Water, Inc.
- BICARB, DUAL, 100, MIX/DEL — Better Water, Inc.
- BICARB, DUAL, 100, MIX/DEL, EDUCTOR — Better Water, Inc.
- BICARB, DUAL, 100, MIX/DEL, SP — Better Water, Inc.
- BICARB, DUAL, 100, MIX/DEL/1000 — Better Water, Inc.
- BICARB, DUAL, 100, MIX/DEL/1000, SP — Better Water, Inc.
- BICARB, DUAL, 60, MIX/DEL, EDUCTOR — Better Water, Inc.
- BICARB, DUAL, 60, MIX/DEL, SP — Better Water, Inc.
- BICARB, SINGLE, 100, MIX-ONLY — Better Water, Inc.
- BICARB, SINGLE, 100, MIX/DEL — Better Water, Inc.
- BICARB, SINGLE, 100, MIX/DEL, SP — Better Water, Inc.
- BICARB, SINGLE, 60, MIX/DEL — Better Water, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Better Water, Inc.
Sources (1)
- FDA UDI 41899728-d84b-4d5d-8c91-84017b24ab86 35 fields · synced May 30, 2026