Product code FIN
- Device name
- Tank, Holding, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140984 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2015-01-12 |
| K141213 | AMERIWATER OZONE DISINFECTION SYSTEM | Ameriwater | 2014-12-10 |
| K112427 | BICARB MIXING AND DISTRIBUTION SYSTEM | Isopure, Corp. | 2012-01-26 |
| K093641 | TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM | Tango3, LLC | 2010-12-08 |
| K060333 | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM | Dialysis Services, Inc. | 2006-09-08 |
| K051031 | AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS | Ameriwater | 2006-01-06 |
| K031502 | USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM | Usfilter | 2004-08-27 |
| K033118 | BIPRO MODEL SDS-CB200 | Medical Solutions International | 2004-06-28 |
| K030366 | BICARD MIXING SYSTEM | Dialysis Systems, Inc. | 2004-04-19 |
| K023011 | OSMONICS SOLUTION DELIVERY SYSTEM | Osmonics Medical Systems | 2003-06-26 |
| K003560 | MAR COR SERVICES BICARB SYSTEM | Mar Cor Services, Inc. | 2001-06-08 |
| K993272 | PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM | Pure Water, Inc. | 2000-04-10 |
| K993058 | PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL | Pure Water, Inc. | 2000-01-24 |
| K992793 | SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM | Better Water, Inc. | 1999-11-16 |
| K970674 | G.E.M. WATER SYSTEMS, INTERNATIONAL | G.E.M. Water Systems | 1997-11-19 |
| K961416 | DIALYSIS MIXING & HOLDING TANK | Dial Medical Supply | 1996-08-21 |
| K883408 | NATURALYTE MIXER | National Medical Care, Medical Products Div., Inc. | 1988-10-31 |
| K873166 | BCM DRY PACK BICARBONATE MIXER | Specialty Dialysis Services | 1987-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| BC0021 | BICARB, DUAL, 100, MIX/DEL, EDUCTOR | BETTER WATER, LLC | 2024-11-13 |
| BC0121 | BICARB, DUAL, 60, MIX/DEL, EDUCTOR | BETTER WATER, LLC | 2024-11-13 |
| 00852456007085 | Sodium Bicarbonate Mixing and Distribution System | Isopure, Corp. | 2017-09-20 |
| B285SDSCB2001 | BiPro Bicarb Mixing/Distribution System | MEDICAL SOLUTIONS INTERNATIONAL, INC. | 2017-06-30 |
| 00817927020314 | AmeriWater 00BCMD100 | AMERIWATER, LLC | 2017-01-10 |
| 00817927020307 | AmeriWater 00BCMD55 | AMERIWATER, LLC | 2017-01-10 |
| 00817927020291 | AmeriWater 00BCM100 | AMERIWATER, LLC | 2017-01-10 |
| 00817927020284 | AmeriWater 00BCM55 | AMERIWATER, LLC | 2017-01-10 |
| 00817927020086 | AmeriWater 0077-0010 Ozone Disinfection System | AMERIWATER, LLC | 2017-01-06 |
| 00817927020079 | AmeriWater 00BC100-200 Bicarb Mix and Distribution System | AMERIWATER, LLC | 2017-01-05 |
| 00817927020062 | AmeriWater 00BC100-100 Bicarb Mix and Distribution System | AMERIWATER, LLC | 2017-01-05 |
| 00817927020055 | AmeriWater 00BC55-55 Bicarb Mix and Distribution System | AMERIWATER, LLC | 2017-01-05 |
| BC0302 | BICARB, SINGLE, 60, MIX-ONLY | BETTER WATER, LLC | 2016-10-13 |
| BC0301 | BICARB, SINGLE, 60, MIX/DEL | BETTER WATER, LLC | 2016-10-13 |
| BC0211 | BICARB, SINGLE, 100, MIX/DEL, SP | BETTER WATER, LLC | 2016-10-13 |
| BC0202 | BICARB, SINGLE, 100, MIX-ONLY | BETTER WATER, LLC | 2016-10-13 |
| BC0201 | BICARB, SINGLE, 100, MIX/DEL | BETTER WATER, LLC | 2016-10-13 |
| BC0111 | BICARB, DUAL, 60, MIX/DEL, SP | BETTER WATER, LLC | 2016-10-13 |
| BC0101 | BICARB, DUAL 60, MIX/DELV | BETTER WATER, LLC | 2016-10-13 |
| BC0012 | BICARB, DUAL, 100, MIX/DEL/1000, SP | BETTER WATER, LLC | 2016-10-13 |
| BC0011 | BICARB, DUAL, 100, MIX/DEL, SP | BETTER WATER, LLC | 2016-10-13 |
| BC0002 | BICARB, DUAL, 100, MIX/DEL/1000 | BETTER WATER, LLC | 2016-10-13 |
| BC0001 | BICARB, DUAL, 100, MIX/DEL | BETTER WATER, LLC | 2016-10-13 |
| 00817492020979 | MCB Series | MAR COR PURIFICATION, INC. | 2016-09-23 |
| 00817492020986 | MCB Series | MAR COR PURIFICATION, INC. | 2016-09-23 |
| 00817492020993 | MCB Series | MAR COR PURIFICATION, INC. | 2016-09-23 |
| 00817492021006 | MCB Series | MAR COR PURIFICATION, INC. | 2016-09-23 |
| 00817492021013 | MCB Series | MAR COR PURIFICATION, INC. | 2016-09-23 |
| 04026704323630 | RUSCH | TELEFLEX INCORPORATED | 2016-09-16 |
| 24026704323634 | RUSCH | TELEFLEX INCORPORATED | 2016-09-16 |