Panels › Gastroenterology, Urology › Product code KPO · Class 2
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation 876.5820
2510(k)s in 12 months (124 all time)
15recalls in 12 months (113 all time)
113recalls that name a 510(k)
Top companies in KPO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius GranuFlo (powder) Acid Concentrate
Product Codes:
OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3 Terminated |
KPO | K030497 |
| Jun 25, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius NaturaLyte Liquid Acid Concentrate
Product Codes:
08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1, Terminated |
KPO | K030497 |
| May 15, 2012 | Fresenius Medical Care Holdings, Inc. Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters)
Cat. No. 13-2251-0.
NaturaLyte liquid acid concentrate is formulated to be used with a three str Terminated |
KPO | K981043 |
| Nov 16, 2011 | Isopure Corp Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.
The Step 2, 3000-2000 GPD chemical is used in the cleaning Terminated |
KPO | K041163 |
| Jun 10, 2011 | Fresenius Medical Care Holdings, Inc. Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid
Part number: 08-4000-LB
Formulated to be used with a three stream hemodialysis machine which is calibr Terminated |
KPO | K071387 |
| Aug 15, 2010 | Fresenius Medical Care North America Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA Terminated |
KPO | K911459 |
| Jan 5, 2009 | Rockwell Medical Technologies, Inc SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure L Terminated |
KPO | K022521 |
| Jan 5, 2009 | Rockwell Medical Technologies, Inc SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure L Terminated |
KPO | K022521 |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc Dri-Sate Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-240); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | K981003 |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc Glacial Acidic Acid (liquid component of Dri-Sate Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | K981003 |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | K954527 |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | K954527 |
| Feb 13, 2008 | Rockwell Medical Technologies, Inc RenalPure Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. Terminated |
KPO | K954527 |
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