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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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NaviCare® Patient Safety Systems - 00887761985193

Medical Software
HILL-ROM, INC.
3.9
In Commercial Distribution

  • 00887761985193 ()


  • Bedside information system application software

NaviCare® SmartSync Systems - 00887761985186

Medical Software
HILL-ROM, INC.
3.9
In Commercial Distribution

  • 00887761985186 ()


  • Bedside information system application software

OrthoNext™ Platform System Software - 18053340345675

ORTHONEXT SOFTWARE
ORTHOFIX SRL
2.0
In Commercial Distribution

  • 18053340345675 ()
ORTHONEXTSW

  • Radiological PACS software

DataTrak - 00886368000841

DataTrak Software
Thermogenesis Corp.
150040
In Commercial Distribution

  • 00886368000841 ()


  • Blood centrifugation system containment kit

Iris - 00886874117538

User Software
INTUITIVE SURGICAL, INC.
610040
In Commercial Distribution

  • 00886874117538 ()


  • Image segmentation application software

iCodeConnect Software - 06948538362075

iCodeConnect Software
BMC Medical Co., Ltd.
420002
In Commercial Distribution

  • 06948538362075 ()


  • Ventilator application software

Holter Software - 00884838000469

No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder

Holter Software - 00884838094895

Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software

ILOv6 Software - 05060396170713

No Description
OTODYNAMICS LIMITED
ILOv6
In Commercial Distribution

  • 05060396170713 ()


  • Otoacoustic emission system, line-powered

EZ-Screen Software - 05060396170706

No Description
OTODYNAMICS LIMITED
EZ-Screen
In Commercial Distribution

  • 05060396170706 ()


  • Otoacoustic emission system, line-powered

TeleSense Software - 00856298006213

Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

SwiftPA Software - 00856264005776

Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator

Novi Software - 00856298006237

Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software

OmniFlow Software - 00858703006313

Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software

IlluminatusDXA Software - 00866955000478

No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software

DermoSight Software - 00860013961411

Web-based software for dermatoscope image capture and analysis
DEEPX HEALTH, LLC
DXH-SW-100
In Commercial Distribution

  • 00860013961411 ()
DXH-SW-100

  • Dermatoscope, optical

Audhere Software - 00860005068319

No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer

PiVAT Software - 00860001218275

The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)

SeeMore Software - 00850921007172

SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007165

SeeMore Software 4.2.1 Urology
INTERSON CORP
4.2.1 URO
In Commercial Distribution

  • 00850921007165 ()
98-3528-03

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007158

SeeMore Software 4.2.1 Generic
INTERSON CORP
4.2.1 GEN
In Commercial Distribution

  • 00850921007158 ()
98-3528-02

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007141

SeeMore Software 4.2.1 OB GYN
INTERSON CORP
4.2.1 OB GYN
In Commercial Distribution

  • 00850921007141 ()
98-3528-01

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007110

SeeMore Software 2.0.03 OB GYN
INTERSON CORP
2.0.03 OB GYN
In Commercial Distribution

  • 00850921007110 ()
98-3517-03

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007103

SeeMore Software 2.0.03 Generic
INTERSON CORP
2.0.03 GEN
In Commercial Distribution

  • 00850921007103 ()
98-3517-00

  • Extracorporeal ultrasound imaging transducer, hand-held

SeeMore Software - 00850921007066

SeeMore Software 2.0.03 Urology
INTERSON CORP
2.0.03 URO
In Commercial Distribution

  • 00850921007066 ()
98-3517-02

  • Extracorporeal ultrasound imaging transducer, hand-held

CERVELLO SOFTWARE - 00850154007086

Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software

WAW SOFTWARE - 05430003362068

The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect to naturalness and density) and the donor (taking care of the donor region). The WAW Duo FUE System is composed of the following: - The WAW Wireless Handpiece: o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external sleeve o Connected via Bluetooth to the tablet o Responsible for the rotation and oscillation movements of the punch (not included) for the FUE, - The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece: o Cleanable (via autoclave) o Connected via a wire to the pedal o Responsible for the rotation and oscillation movements of the punch for the FUE, - The WAW Pedal, responsible for activating the handpieces, - The WAW Software, responsible for defining the parameters of functioning (rotation and oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the pedal (the Samsung tablet is supplied), - The WAW Charging Station, intended to recharge the wireless handpiece and - The External Sleeve Support Box, intended to sustain external parts of WAW Wireless Handpiece and WAW Wired Handpiece during autoclave process. - Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
0.1.35
In Commercial Distribution

  • 05430003362068 ()


  • Electrosurgical handpiece, reusable

Zensor+ software - 05060484630051

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution

  • 05060484630051 ()


  • Electrocardiography telemetric monitoring system

Zensoronline software - 05060484630044

The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together. The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician. The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution

  • 05060484630044 ()


  • Electrocardiography telemetric monitoring system

3DSRW Software - 03701311500445

No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software

NeXus Software - 08719481550332

The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software

sUSBA Software - 04056869006833

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149925
Not in Commercial Distribution

  • 04056869006833 ()


  • Radiological PACS software

Actical Software - 00606959021013

Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution

  • 00606959021013 ()
1081738

  • Kinesiology ambulatory recorder

Aurix Software - 00627908090027

Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer

Integrity Software - 00627908090010

Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

Millennia Software - B146C4MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-08
In Commercial Distribution

  • B146C4MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA020

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-02
In Commercial Distribution

  • B146C4MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA000

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-00
In Commercial Distribution

  • B146C4MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-08
In Commercial Distribution

  • B146C3MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA070

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-07
In Commercial Distribution

  • B146C3MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA050

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-05
In Commercial Distribution

  • B146C3MA050 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA020

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-02
In Commercial Distribution

  • B146C3MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA00

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-00
In Commercial Distribution

  • B146C3MA00 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C2MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0619-08
In Commercial Distribution

  • B146C2MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C2MA000

No Description
BRAEMAR MANUFACTURING, LLC
900-0619-00
In Commercial Distribution

  • B146C2MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0618-08
In Commercial Distribution

  • B146C1MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA070

No Description
BRAEMAR MANUFACTURING, LLC
900-0618-07
In Commercial Distribution

  • B146C1MA070 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA051010

The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-05
In Commercial Distribution

  • B146C1MA051010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C1MA031010

The Millennia Software system is indicated for: Cardiac evaluation of heart rate and rhythm in patients experiencing syncope, near syncope, dizziness, palpitations, shortness of breath, chest pain and transient arrhythmias. To assess risk for future cardiac events in patients without symptoms from arrhythmia who have been diagnosed with congestive heart failure, idiopathic hypertrophic cardiomyopathy, and post myocardial infarction with left ventricular dysfunction. Assessment of drug response in patients taking antiarrhythmic medications. Baseline frequency of the arrhythmia should be characterized as reproducible and of sufficient frequency to permit evaluation. ST segment analysis in patients with known coronary heart disease, chest pain, and suspected variant angina.
BRAEMAR MANUFACTURING, LLC
900-0618-03
In Commercial Distribution

  • B146C1MA031010 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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