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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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LiDCO Ltd - 05060110520664

Cable Assembly, PulseCO to Marquette TRAM 451
LIDCO LIMITED
Li10334
In Commercial Distribution

  • 05060110520664 ()
Li10334

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520657

Cable Assembly, PulseCO to Datex S/5 with B-UPI4
LIDCO LIMITED
Li10287
In Commercial Distribution

  • 05060110520657 ()
Li10287

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520640

Cable Assembly, PulseCO to Fukuda Denshi HS500 Module
LIDCO LIMITED
Li10282
In Commercial Distribution

  • 05060110520640 ()
Li10282

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520633

Cable Assembly, PulseCO to Philips M116X, Option J11
LIDCO LIMITED
Li10251
In Commercial Distribution

  • 05060110520633 ()
Li10251

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520626

Cable Assembly, PulseCO to Siemens/Draeger Infinity Monitor
LIDCO LIMITED
Li10168
In Commercial Distribution

  • 05060110520626 ()
Li10168

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520619

Cable Assembly, PulseCO to Datex-Ohmeda M-PT Module
LIDCO LIMITED
Li10166
In Commercial Distribution

  • 05060110520619 ()
Li10166

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520602

Cable Assembly, PulseCO to Philips #C01 BP Module
LIDCO LIMITED
Li10162
In Commercial Distribution

  • 05060110520602 ()
Li10162

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520596

Cable Assembly, PulseCO-Datex S/3&5 Dig&Analog I/O Cnc
LIDCO LIMITED
Li10158
In Commercial Distribution

  • 05060110520596 ()
Li10158

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520589

Cable Assembly, PulseCO to Spacelab’s BP Monitors
LIDCO LIMITED
Li10156
In Commercial Distribution

  • 05060110520589 ()
Li10156

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520572

Cable Assembly, PulseCO to Marquette BP Monitor
LIDCO LIMITED
Li10107
In Commercial Distribution

  • 05060110520572 ()
Li10107

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520565

Cable Assembly, PulseCO to BNC BP Monitor
LIDCO LIMITED
Li10106
In Commercial Distribution

  • 05060110520565 ()
Li10106

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520558

Pole/Rail Mounting Assembly, POC-125 Monitor Platform
LIDCO LIMITED
Li10593
In Commercial Distribution

  • 05060110520558 ()
Li10593

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520541

Desktop Stand Mounting Assembly, POC-125 Monitor Platform
LIDCO LIMITED
Li10592
In Commercial Distribution

  • 05060110520541 ()
Li10592

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520534

Smartcard, Demo, LiDCOrapid, 10,000 Minutes
LIDCO LIMITED
Li10554
In Commercial Distribution

  • 05060110520534 ()
Li10554

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520343

Smartcard, Demo, LiDCOrapid, 600,000 Minutes,LiDCO Internal Use Only
LIDCO LIMITED
Li10529
In Commercial Distribution

  • 05060110520343 ()
Li10529

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520329

Smartcard, LiDCOrapid, CNAP, Li Calibration, 7 Days, Single Patient, Single
LIDCO LIMITED
Li10949
In Commercial Distribution

  • 15060110520326 ()
  • 05060110520329 ()
Not a catalog item

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520312

LiDCO Sensor Simulator
LIDCO LIMITED
CM 35-02
In Commercial Distribution

  • 05060110520312 ()
CM 35-02

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520305

PulseCO Simulator
LIDCO LIMITED
CM 35-01
In Commercial Distribution

  • 05060110520305 ()
CM 35-01

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520299

Desktop/Pole/Rail Mounting Assembly, POC-125 Monitor Platform
LIDCO LIMITED
Li10545
In Commercial Distribution

  • 05060110520299 ()
Li10545

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520282

LiDCOrapid Hemodynamic Assembly, comprising of:
LIDCO LIMITED
HM 81-01 ASSEMBLY
In Commercial Distribution

  • 05060110520282 ()
HM 81-01 ASSEMBLY

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520275

LiDCOplus Hemodynamic Assembly, comprising of:
LIDCO LIMITED
HM 71-02 PLUS
In Commercial Distribution

  • 05060110520275 ()
HM 71-02 PLUS

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520251

Lithium Chloride Injection 0.15mmol/ml, US, 10ml, Single
LIDCO LIMITED
CM 40
In Commercial Distribution

  • 15060110520258 ()
  • 05060110520251 ()

  • Total Volume: 10.0 Milliliter
Not a catalog item

  • General-purpose multi-parameter bedside monitor

LiDCO Ltd - 05060110520107

LiDCO Sensor, Pre-Advanced, Single
LIDCO LIMITED
CM 10 PAS
In Commercial Distribution

  • 15060110520104 ()
  • 05060110520107 ()
Not a catalog item

  • General-purpose multi-parameter bedside monitor

Hypotension Decision Assist (HDA) - 00860003496718

Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR2
In Commercial Distribution

  • 00860003496718 ()


  • Clinical management support software

Hypotension Decision Assist (HDA) - 00860003496701

Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters. HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
DIRECTED SYSTEMS LIMITED
HDA-OR1
In Commercial Distribution

  • 00860003496701 ()


  • Clinical management support software

Transonic - 00877466000406

No Description
TRANSONIC SYSTEMS INC.
H9FX
In Commercial Distribution

  • 00877466000406 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 00877466000390

No Description
TRANSONIC SYSTEMS INC.
H7FX
In Commercial Distribution

  • 00877466000390 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 00877466000383

No Description
TRANSONIC SYSTEMS INC.
H6FX
In Commercial Distribution

  • 00877466000383 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 00877466000376

No Description
TRANSONIC SYSTEMS INC.
HCE101
In Commercial Distribution

  • 00877466000376 ()


  • Noninvasive vascular ultrasound system, line-powered

Transonic - 00877466000369

No Description
TRANSONIC SYSTEMS INC.
HCS3002-5
In Commercial Distribution

  • 00877466000369 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000352

No Description
TRANSONIC SYSTEMS INC.
HCS3021-5
In Commercial Distribution

  • 00877466000352 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000345

No Description
TRANSONIC SYSTEMS INC.
HCS3012-5
In Commercial Distribution

  • 00877466000345 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000338

No Description
TRANSONIC SYSTEMS INC.
HCS3011-5
In Commercial Distribution

  • 00877466000338 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000321

No Description
TRANSONIC SYSTEMS INC.
HCP01
In Commercial Distribution

  • 00877466000321 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000307

No Description
TRANSONIC SYSTEMS INC.
HC2T
In Commercial Distribution

  • 00877466000307 ()


  • Thermal-dilution cardiac output unit

Transonic - 00877466000277

No Description
TRANSONIC SYSTEMS INC.
HCM101
In Commercial Distribution

  • 00877466000277 ()


  • Thermal-dilution cardiac output unit

MicroFit - 00868127000200

Multi-component device that connects to a user’s PC computer for measurement, tracking, and reporting of body weight and blood pressure. Device consists of a stand-on body weight scale, non-invasive automatic blood pressure monitor, analog to digital interface unit (CTI), and software (to be installed on the user’s PC computer).
MICROFIT, INC.
FAS-2
In Commercial Distribution

  • 00868127000200 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Stand-on floor scale, electronic

NA - 00690103008463

OXIMETRY OPTICAL MODULE
Edwards Lifesciences LLC
OM2
In Commercial Distribution

  • 00690103008463 ()

  • Length: 10 Feet
OM2

  • General-purpose multi-parameter bedside monitor

NA - 00690103005271

BIFURCATED CATH CONNECTING CABLW W/INJ. CONN. F/COM-2 COC
Edwards Lifesciences LLC
COM2CC
In Commercial Distribution

  • 00690103005271 ()

  • Length: 8 Feet
COM2CC

  • Electrical-only medical device connection cable, reusable

CO-SET+ - 00690103004250

INJECTATE TEMPERATURE PROBE
Edwards Lifesciences LLC
9850A
In Commercial Distribution

  • 00690103004250 ()

  • Length: 120 Inch
9850A

  • General-purpose patient temperature probe, reusable

SWAN-GANZ - 00690103002799

CABLE CCO CATHETER INTERFACE
Edwards Lifesciences LLC
70CC2
In Commercial Distribution

  • 00690103002799 ()

  • Length: 8 Feet
70CC2

  • Electrical-only medical device connection cable, reusable

NA - 00690103002782

ANALOG SLAVE CABLE W/ Y CONN FOR SPACELABS
Edwards Lifesciences LLC
70ANSS
In Commercial Distribution

  • 00690103002782 ()

  • Length: 8 Feet
70ANSS

  • Electrical-only medical device connection cable, reusable

NA - 00690103002775

PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
70ANS
In Commercial Distribution

  • 00690103002775 ()

  • Length: 8 Feet
70ANS

  • Electrical-only medical device connection cable, reusable

NA - 00690103002768

PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
70ANNK
In Commercial Distribution

  • 00690103002768 ()

  • Length: 8 Feet
70ANNK

  • Electrical-only medical device connection cable, reusable

NA - 00690103002737

PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
70ANM5
In Commercial Distribution

  • 00690103002737 ()

  • Length: 8 Feet
70ANM5

  • Electrical-only medical device connection cable, reusable

NA - 00690103002676

PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
70ANHS
In Commercial Distribution

  • 00690103002676 ()

  • Length: 8 Feet
70ANHS

  • Electrical-only medical device connection cable, reusable

NA - 00690103002614

CABLE,SLAVE F/VIGILANCE N/S
Edwards Lifesciences LLC
70ANH
In Commercial Distribution

  • 00690103002614 ()

  • Length: 8 Feet
70ANH

  • Electrical-only medical device connection cable, reusable

NA - 00690103002508

CABLE,EKG SLAVE 64-EKM AND Y CONN F/MARQUETTE 7010/TRAM
Edwards Lifesciences LLC
64EKMM
In Commercial Distribution

  • 00690103002508 ()

  • Length: 8 Feet
64EKMM

  • Electrocardiographic lead set, reusable

NA - 00690103002485

ECG SLAVE CABLE
Edwards Lifesciences LLC
64EKLL
In Commercial Distribution

  • 00690103002485 ()

  • Length: 8 Feet
64EKLL

  • Electrocardiographic lead set, reusable

NA - 00690103002478

CABLE,EKG SLAVE 64-EKH AND Y CONN F/HP MERLIN, HP CLOV
Edwards Lifesciences LLC
64EKHH
In Commercial Distribution

  • 00690103002478 ()

  • Length: 8 Feet
64EKHH

  • Electrocardiographic lead set, reusable
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