510(k) K111174 ยท FKR Subsystem, Proportioning
NXSTAGE PUREFLOW SL
| Applicant | Nxstage Medical, Inc., Lawrence MA, US |
| Decision | Substantially Equivalent, Sep 19, 2011 |
| Received | Apr 27, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111174
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.