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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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CONNECTING CABLE APCO9
Edwards Lifesciences LLC
APCO9
In Commercial Distribution

  • 00690103165418 ()

  • Length: 108 Inch
APCO9

  • Electrical-only medical device connection cable, reusable
VIGILEO ANALOG SLAVE CABLE, DATEX DIN7
Edwards Lifesciences LLC
MHFD1
In Commercial Distribution

  • 00690103187267 ()

  • Length: 96 Inch
MHFD1

  • Electrical-only medical device connection cable, reusable
CONNECTING CABLE APCO9X2
Edwards Lifesciences LLC
APCO9X2
In Commercial Distribution

  • 00690103184976 ()

  • Length: 216 Inch
APCO9X2

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANNK
In Commercial Distribution

  • 00690103181456 ()

  • Length: 8 Feet
MHANNK

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANM8
In Commercial Distribution

  • 00690103186093 ()

  • Length: 8 Feet
MHANM8

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHAND
In Commercial Distribution

  • 00690103181449 ()

  • Length: 8 Feet
MHAND

  • Electrical-only medical device connection cable, reusable
PRESSURE SLAVE CABLE
Edwards Lifesciences LLC
MHANM5
In Commercial Distribution

  • 00690103181418 ()

  • Length: 8 Feet
MHANM5

  • Electrical-only medical device connection cable, reusable
DeepRhythmAI is a cloud-based software that utilizes AI algorithms to assess cardiac arrhythmias using a single- or two-lead ECG data from adult patients. It is intended for use by a healthcare solution integrator to build web, mobile or another types of applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analyzing data recorded in the compatible formats from ECG devices such as Holter, Event recorder, Outpatient Cardiac Telemetry devices or other similar recorders when the assessment of the rhythm is necessary. The product can be electronically interfaced and perform analysis with data transferred from other computer-based ECG systems, such as an ECG management system. DeepRhythmAI can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device. DeepRhythmAI is not for use in life-supporting or sustaining systems or ECG Alarm devices. Interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG patterns, patient background, clinical history, symptoms and other diagnostic information.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution

  • 05903021560742 ()


  • Cardiopulmonary physiological parameter analysis software
The DeepRhythmAI (DRAI) is a cloud-based software for automated analysis of ECG data. It uses a scalable Application Programming Interface (API) to enable easy integration. The main component of DeepRhythmAI is an automated proprietary deep-learning algorithm, which measures and analyzes ECG data to provide qualified healthcare professional with supportive information for review. DeepRhythmAI can be integrated into medical devices.
MEDICALGORITHMICS S A
Type: DRAI
In Commercial Distribution

  • 05903021560131 ()


  • Cardiopulmonary physiological parameter analysis software
Cart 48 Inch
ST. JUDE MEDICAL, INC.
H701313
In Commercial Distribution

  • 05415067013132 ()
H701313

  • Cardiac catheterization monitoring system
Cart 24 Inch
ST. JUDE MEDICAL, INC.
H701312
In Commercial Distribution

  • 05415067013125 ()
H701312

  • Cardiac catheterization monitoring system
Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
CARDIAC INSIGHT, INC.
C300/D300
In Commercial Distribution

  • 00857553006122 ()
  • 10857553006129 ()
C300/D300

  • Electrocardiographic ambulatory recorder
Cardea SOLO Wearable Sensor (M300)
CARDIAC INSIGHT, INC.
M300-5
In Commercial Distribution

  • 10857553006112 ()
  • 00857553006115 ()
M300-5

  • Electrocardiographic ambulatory recorder
No Description
Siemens Healthcare GmbH
11060620
In Commercial Distribution

  • 04056869026367 ()


  • Full-body CT system
No Description
ATsens.co.,Ltd.
ATP-C130
In Commercial Distribution

  • 18800069700175 ()
  • 08800069700178 ()
  • 28800069700172 ()


  • Electrocardiographic long-term ambulatory recording analyser
PACKAGE, EVO AND PATHFINDER SL
SPACELABS HEALTHCARE (WASHINGTON), INC
EVO Recorder
In Commercial Distribution

  • 10841522127229 ()
040-1761-00

  • Electrocardiographic ambulatory recorder
  • Electrocardiographic long-term ambulatory recording analyser
No Description
Avante
60130H
In Commercial Distribution

  • 00815871021425 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 14D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250142 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 7D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250074 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT Installation Kit - ECG Recorder 2D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250029 ()


  • Electrocardiographic ambulatory recorder
Stealth System Wearable Sensor (M300).
CARDIAC INSIGHT, INC.
M300-5
Not in Commercial Distribution

  • 20857553006072 ()
  • 00857553006078 ()
M300-5

  • Electrocardiographic ambulatory recorder
8mm Stapler
INTUITIVE SURGICAL, INC.
488530
In Commercial Distribution

  • 10886874121723 ()
  • 00886874121726 ()

  • Outer Diameter: 8 Millimeter
  • Length: 30 Millimeter


  • Robotic surgical cutting stapler, reusable
CardioSTAT ECG Recorder 14D test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200140 ()
  • 27540279200147 ()


  • Electrocardiographic ambulatory recorder
CardioSTAT ECG Recorder 7D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200072 ()
  • 27540279200079 ()


  • Electrocardiographic ambulatory recorder
ECG Analysis and Reporting Tool.
Icentia Inc.
10-501
In Commercial Distribution

  • 17540279105018 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
45mm Curved Tip Stapler
INTUITIVE SURGICAL, INC.
436504
In Commercial Distribution

  • 10886874123659 ()
  • 00886874123652 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
45mm Straight Tip Stapler
INTUITIVE SURGICAL, INC.
436502
In Commercial Distribution

  • 10886874123642 ()
  • 00886874123645 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
8mm Stapler
INTUITIVE SURGICAL, INC.
48230M
In Commercial Distribution

  • 10886874121938 ()
  • 00886874121931 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230W
In Commercial Distribution

  • 10886874121921 ()
  • 00886874121924 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
8mm Stapler
INTUITIVE SURGICAL, INC.
48230B
In Commercial Distribution

  • 10886874121914 ()
  • 00886874121917 ()

  • Depth: 30 Millimeter


  • Surgical staple loading unit, non-cutting
SureForm 45 Curved-Tip
INTUITIVE SURGICAL, INC.
480545
In Commercial Distribution

  • 10886874117597 ()
  • 00886874117590 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SureForm 45
INTUITIVE SURGICAL, INC.
480445
In Commercial Distribution

  • 10886874117580 ()
  • 00886874117583 ()

  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
SUREFORM 45 RELOAD WHITE
INTUITIVE SURGICAL, INC.
48345W
In Commercial Distribution

  • 10886874117122 ()
  • 00886874117125 ()

  • Depth: 2.5 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLACK
INTUITIVE SURGICAL, INC.
48345T
In Commercial Distribution

  • 10886874117115 ()
  • 00886874117118 ()

  • Depth: 4.6 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GRAY
INTUITIVE SURGICAL, INC.
48345M
In Commercial Distribution

  • 10886874117108 ()
  • 00886874117101 ()

  • Depth: 2 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD GREEN
INTUITIVE SURGICAL, INC.
48345G
In Commercial Distribution

  • 10886874117092 ()
  • 00886874117095 ()

  • Depth: 4.3 Millimeter


  • Surgical staple loading unit, non-cutting
SUREFORM 45 RELOAD BLUE
INTUITIVE SURGICAL, INC.
48345B
In Commercial Distribution

  • 10886874117085 ()
  • 00886874117088 ()

  • Depth: 3.5 Millimeter


  • Surgical staple loading unit, non-cutting
No Description
Atlas Lift Tech, Inc.
SE
Not in Commercial Distribution

  • 11968525122705 ()


  • Wireless patient monitor/sensor reporting software, professional-only
A reusable, wireless, Bluetooth device that sends patient body orientation and movement information to the Bedside Mobility Monitor (BMM) that is housed within the Atlas Wearable Patch.
Atlas Lift Tech, Inc.
Rev A
In Commercial Distribution

  • 00860008806024 ()


  • Wireless patient monitor/sensor reporting software, professional-only
PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CVA01
In Commercial Distribution

  • 00195278330413 ()
5863721

  • Wireless patient monitor/sensor reporting software, professional-only
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