Panels › Gastroenterology, Urology › Product code FKR · Class 2
Subsystem, Proportioning
Regulation 876.5820
0510(k)s in 12 months (12 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in FKR
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2018 | NxStage Medical, Inc. NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 U Terminated |
FKR | K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-407
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-307
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-306
Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-305
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) 40 Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) 6 Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-303
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m
Chloride 100m, Glucose (mg/dL) 100
Batch Size (liter Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-302
Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100,
Batch Size (lite Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-301
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jan 20, 2012 | NxStage Medical, Inc. NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx
The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate Terminated |
FKR | K080919 K111174 |
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