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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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Leica Biosystems CytoVision HD with Image, Dell T7500 RAID 1, Win 7 - 00849832009894

Leica Biosystems CytoVision HD with Image, Dell T7500 RAID 1, Win 7
Leica Biosystems Richmond, Inc.
23DKI7517
Not in Commercial Distribution

  • 00849832009894 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro - 00849832009887

Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5817
Not in Commercial Distribution

  • 00849832009887 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Ultimate - 00849832009870

Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5810
Not in Commercial Distribution

  • 00849832009870 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro - 00849832009863

Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5807
Not in Commercial Distribution

  • 00849832009863 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Leica Biosystems CytoVision HD Image, Dell 5810 Basic, Win 7 Ultimate - 00849832009856

Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5800
Not in Commercial Distribution

  • 00849832009856 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive

Defibtech AirAware Remote ASI Cellular Module - 00815098020706

No Description
DEFIBTECH, L.L.C.
DCM-U1613
In Commercial Distribution

  • 10815098020703 ()
  • 00815098020706 ()


  • Computer network router

NZ Technologies Inc - 07540293000033

Router for Tipso Airpad (TIPSO Router)
NZ Technologies Inc
Archer 20
In Commercial Distribution

  • 07540293000033 ()


  • Computer mouse/roller-ball

NZ Technologies Inc - 07540293000026

Charging Dock (TIPSO AirPad® Charger)
NZ Technologies Inc
APADCHG-APL2
In Commercial Distribution

  • 07540293000026 ()


  • Computer mouse/roller-ball

NZ Technologies Inc - 07540293000019

TIPSO USB Dongle
NZ Technologies Inc
UDNG-UD4
In Commercial Distribution

  • 07540293000019 ()


  • Computer mouse/roller-ball

NZ Technologies Inc - 07540293000002

Tipso Airpad (A wireless controller)
NZ Technologies Inc
APAD-APL2
In Commercial Distribution

  • 07540293000002 ()


  • Computer mouse/roller-ball

Z-DOSE29 - 00810040260001

XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT system computer

SafeCT-29 - 07290016836202

Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer’s internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT- 29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.0
In Commercial Distribution

  • 07290016836202 ()
  • 00729001683639 ()


  • CT system computer

SleepScout - B14350201490

SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350201490 ()
502-0149

  • Electroencephalograph

SleepScout - B14350101320

Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350101320 ()
502-0132

  • Electroencephalograph

Zurich Medical Accessory Cable - 00850022994357

No Description
ZURICH MEDICAL INC.
Draeger-Siemens 14-Pin, Type I
In Commercial Distribution

  • 00850022994357 ()
512-034

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994340

No Description
ZURICH MEDICAL INC.
Draeger-Siemens 14-Pin, Type G
In Commercial Distribution

  • 00850022994340 ()
512-033

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994333

No Description
ZURICH MEDICAL INC.
Draeger-Siemens 14-Pin, Type C
In Commercial Distribution

  • 00850022994333 ()
512-032

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994326

No Description
ZURICH MEDICAL INC.
Draeger-Siemens 14-Pin, Type A
In Commercial Distribution

  • 00850022994326 ()
512-031

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994296

No Description
ZURICH MEDICAL INC.
Siemens 8-Pin, Type I
In Commercial Distribution

  • 00850022994296 ()
512-144

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994289

No Description
ZURICH MEDICAL INC.
Siemens 8-Pin, Type G
In Commercial Distribution

  • 00850022994289 ()
512-143

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994272

No Description
ZURICH MEDICAL INC.
Siemens 8-Pin, Type C
In Commercial Distribution

  • 00850022994272 ()
512-142

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994265

No Description
ZURICH MEDICAL INC.
Siemens 8-Pin, Type A
In Commercial Distribution

  • 00850022994265 ()
512-141

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994173

No Description
ZURICH MEDICAL INC.
Merge 3.5mm, Type I
In Commercial Distribution

  • 00850022994173 ()
512-134

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994166

No Description
ZURICH MEDICAL INC.
Merge 3.5mm, Type G
In Commercial Distribution

  • 00850022994166 ()
512-133

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994159

No Description
ZURICH MEDICAL INC.
Merge 3.5mm, Type C
In Commercial Distribution

  • 00850022994159 ()
512-132

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994142

No Description
ZURICH MEDICAL INC.
Merge 3.5mm, Type A
In Commercial Distribution

  • 00850022994142 ()
512-131

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994128

No Description
ZURICH MEDICAL INC.
GE 9-Pin, Type I
In Commercial Distribution

  • 00850022994128 ()
512-024

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994111

No Description
ZURICH MEDICAL INC.
GE 9-Pin, Type G
In Commercial Distribution

  • 00850022994111 ()
512-023

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994104

No Description
ZURICH MEDICAL INC.
GE 9-Pin, Type C
In Commercial Distribution

  • 00850022994104 ()
512-022

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994098

No Description
ZURICH MEDICAL INC.
GE 9-Pin, Type A
In Commercial Distribution

  • 00850022994098 ()
512-021

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994081

No Description
ZURICH MEDICAL INC.
Philips BNC, Type I
In Commercial Distribution

  • 00850022994081 ()
512-124

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994074

No Description
ZURICH MEDICAL INC.
Philips BNC, Type G
In Commercial Distribution

  • 00850022994074 ()
512-123

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994067

No Description
ZURICH MEDICAL INC.
Philips BNC, Type C
In Commercial Distribution

  • 00850022994067 ()
512-122

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994050

No Description
ZURICH MEDICAL INC.
Philips BNC, Type A
In Commercial Distribution

  • 00850022994050 ()
512-121

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994043

No Description
ZURICH MEDICAL INC.
GE 7-Pin, Type I
In Commercial Distribution

  • 00850022994043 ()
512-004

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994036

No Description
ZURICH MEDICAL INC.
GE 7-Pin, Type G
In Commercial Distribution

  • 00850022994036 ()
512-003

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994029

No Description
ZURICH MEDICAL INC.
GE-7-Pin, Type C
In Commercial Distribution

  • 00850022994029 ()
512-002

  • Electrical-only medical device connection cable, reusable

Zurich Medical Accessory Cable - 00850022994012

No Description
ZURICH MEDICAL INC.
GE-7-Pin, Type A
In Commercial Distribution

  • 00850022994012 ()
512-001

  • Electrical-only medical device connection cable, reusable

NA - 05415067016287

ECG/AO Cable Kit
ST. JUDE MEDICAL, INC.
C12507
In Commercial Distribution

  • 05415067016287 ()
C12507

  • Electrical-only medical device connection cable, reusable

NA - 05415067015075

Cable
ST. JUDE MEDICAL, INC.
Adapter Cable
In Commercial Distribution

  • 05415067015075 ()
C12640

  • Electrical-only medical device connection cable, reusable

NA - 05415067015068

Transducer Cable
ST. JUDE MEDICAL, INC.
C12639
In Commercial Distribution

  • 05415067015068 ()
C12639

  • Electrical-only medical device connection cable, reusable

NA - 05415067011824

Adapter Cable
ST. JUDE MEDICAL, INC.
C12602
In Commercial Distribution

  • 05415067011824 ()
C12602

  • Electrical-only medical device connection cable, reusable

NA - 05415067010711

Transducer Cable
ST. JUDE MEDICAL, INC.
C12688
In Commercial Distribution

  • 05415067010711 ()
C12688

  • Electrical-only medical device connection cable, reusable

NA - 05415067010704

Transducer Cable
ST. JUDE MEDICAL, INC.
C12687
In Commercial Distribution

  • 05415067010704 ()
C12687

  • Electrical-only medical device connection cable, reusable

NA - 05415067010698

Transducer Cable
ST. JUDE MEDICAL, INC.
C12686
In Commercial Distribution

  • 05415067010698 ()
C12686

  • Electrical-only medical device connection cable, reusable

NA - 05415067010681

Transducer Cable
ST. JUDE MEDICAL, INC.
C12685
In Commercial Distribution

  • 05415067010681 ()
C12685

  • Electrical-only medical device connection cable, reusable

NA - 05415067010674

Transducer Cable
ST. JUDE MEDICAL, INC.
C12684
In Commercial Distribution

  • 05415067010674 ()
C12684

  • Electrical-only medical device connection cable, reusable

NA - 05414734054690

Monitor Cable
ST. JUDE MEDICAL, INC.
12964
In Commercial Distribution

  • 05414734054690 ()
12964

  • Electrical-only medical device connection cable, reusable

PressureWire™ - 05414734051965

Cable
ST. JUDE MEDICAL, INC.
12960
In Commercial Distribution

  • 05414734051965 ()
12960

  • Electrical-only medical device connection cable, reusable

PressureWire™ - 05414734051941

Cable
ST. JUDE MEDICAL, INC.
12954
In Commercial Distribution

  • 05414734051941 ()
12954

  • Electrical-only medical device connection cable, reusable
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