Panels › Cardiovascular › Product code DRS · Class 2
Transducer, Blood-Pressure, Extravascular
Regulation 870.2850
1510(k)s in 12 months (149 all time)
2recalls in 12 months (236 all time)
226recalls that name a 510(k)
Top companies in DRS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2016 | ICU Medical, Inc. 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a ca Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) i Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extr Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and Bracket, Item Nos. 46107-35, 46110-07
Usage:
The Transpac Disposable Straight Pressure Transd Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressur Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53
Usage:
The Transpac Disposable Straight Pressure Transducer (DS Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. 5 Port OFF Manifold with Transpac IV, Item No. 46100-29
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Pediatric Kit with 30mL Flush Device, Item No. 46099-10
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Bifurcated SafeSet Kit with 03mL Flush Device, Item No. 46091-75
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces b Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. SafeSet Kit with 30 mL Flush Device, Item No. 46083-42
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with 03mL Flush Device, Item No. 46080-57
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces b Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Triple Line SafeSet Kit with 03mL Flush Device, Item No. 46076-27
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Monitoring Kit with 30mL Flush Device, Item No. 46076-15
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Single Monitoring Kit with 30mL Flush Device, Item No. 46073-38
Product Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66
Product Usage:
The Transpac Disposable Straight Pressure Transducer ( Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06
Product Usa Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06
Product Usage:
The Tr Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66
Usage:
The Transpac Disposable Straight Pressure Tr Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06
Usage:
The Transpac Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08
Usage:
The Transpac Disposable Stra Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Bifurcated Kit with SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 42500-66
Usage:
The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascula Terminated |
DRS | K061573 K932188 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04
Usage:
The Transpac Di Terminated |
DRS | K061573 |
| Sep 15, 2016 | ICU Medical, Inc. Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66
Usage:
The Transpac Disposable Straight Pressure Tra Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling po Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sa Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring k Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling por Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flus Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampl Terminated |
DRS | K061573 |
| Aug 7, 2014 | ICU Medical, Inc. Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52
Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze f Terminated |
DRS | K061573 |
| Sep 11, 2013 | Edwards Lifesciences, LLC "***Flo Trac Sensor Model MHD85***"
Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. Terminated |
DRS | K043065 |
| Jun 13, 2013 | Utah Medical Products, Inc Deltran Disposable Pressure Transducer Kit (DPT Kit)
Extracorporeal disposable pressure transducer and tubing set with integral stopcock and flush device,
Product Usage: Deltran is a disposable Terminated |
DRS | None listed |
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