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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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Lutech - B299750MCP0

Multi-parameter patient monitor. 750-M-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750MC0

Multi-parameter patient monitor. 750-M-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750MC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750M0

Multi-parameter patient monitor. 750-M
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750M0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LP0

Multi-parameter patient monitor. 750-L-P.
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIP0

Multi-parameter patient monitor. 750-L-I-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LICP0

Multi-parameter patient monitor. 750-L-IC-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LICP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LIC0

Multi-parameter patient monitor. 750-L-IC
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LIC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LI0

Multi-parameter patient monitor. 750-L-I
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LI0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LCP0

Multi-parameter patient monitor. 750-L-C-P
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LCP0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750LC0

Multi-parameter patient monitor. 750-L-C
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750LC0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Lutech - B299750L0

Multi-parameter patient monitor. 750-L
LUTECH INDUSTRIES INC
Datalys 750
In Commercial Distribution

  • B299750L0 ()


  • Multiple vital physiological parameter monitoring system, clinical

Fetal Monitor Remote Display - B321600226110010

No Description
CLINICOMP INTERNATIONAL, INC.
27" Wall Mount
In Commercial Distribution

  • B321600226110010 ()

  • Depth: 5 Inch
  • Height: 24 Inch
  • Width: 14.5 Inch
  • Weight: 16 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B32160022611001

No Description
CLINICOMP INTERNATIONAL, INC.
27" Wall Mount
In Commercial Distribution

  • B32160022611001 ()

  • Depth: 5 Inch
  • Height: 24 Inch
  • Width: 14.5 Inch
  • Weight: 16 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600226110

No Description
CLINICOMP INTERNATIONAL, INC.
27" DeskTop
In Commercial Distribution

  • B321600226110 ()

  • Depth: 9 Inch
  • Height: 21.5 Inch
  • Width: 24 Inch
  • Weight: 18 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B32160022611

No Description
CLINICOMP INTERNATIONAL, INC.
27" DeskTop
In Commercial Distribution

  • B32160022611 ()

  • Depth: 9 Inch
  • Height: 21.5 Inch
  • Width: 24 Inch
  • Weight: 18 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600226100010

No Description
CLINICOMP INTERNATIONAL, INC.
27 Wall Mount
In Commercial Distribution

  • B321600226100010 ()

  • Depth: 3.5 Inch
  • Width: 24 Inch
  • Height: 17 Inch
  • Weight: 24 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600226100

No Description
CLINICOMP INTERNATIONAL, INC.
27 DeskTop
In Commercial Distribution

  • B321600226100 ()

  • Depth: 8 Inch
  • Width: 24 Inch
  • Height: 20 Inch
  • Weight: 30 Pound


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600226000010

No Description
CLINICOMP INTERNATIONAL, INC.
27 Wall Mount
In Commercial Distribution

  • B321600226000010 ()

  • Weight: 24 Pound
  • Height: 17 Inch
  • Width: 24 Inch
  • Depth: 3.5 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600226000

No Description
CLINICOMP INTERNATIONAL, INC.
27 DeskTop
In Commercial Distribution

  • B321600226000 ()

  • Weight: 30 Pound
  • Height: 20 Inch
  • Width: 24 Inch
  • Depth: 8 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600225000

No Description
CLINICOMP INTERNATIONAL, INC.
27 DeskTop
In Commercial Distribution

  • B321600225000 ()

  • Weight: 36 Pound
  • Height: 19 Inch
  • Width: 26 Inch
  • Length: 10 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321600225000010

No Description
CLINICOMP INTERNATIONAL, INC.
27 Wall Mount
In Commercial Distribution

  • B321600225000010 ()

  • Weight: 30 Pound
  • Height: 17 Inch
  • Width: 26 Inch
  • Length: 10 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598226010

No Description
CLINICOMP INTERNATIONAL, INC.
NUC8i3BEK
In Commercial Distribution

  • B321598226010 ()

  • Weight: 1.5 Pound
  • Height: 1.25 Inch
  • Depth: 4.25 Inch
  • Width: 4.5 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B32159822601

No Description
CLINICOMP INTERNATIONAL, INC.
NUC8i3BEK
In Commercial Distribution

  • B32159822601 ()

  • Weight: 1.5 Pound
  • Height: 1.25 Inch
  • Depth: 4.25 Inch
  • Width: 4.5 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598226000

No Description
CLINICOMP INTERNATIONAL, INC.
4K 55
In Commercial Distribution

  • B321598226000 ()

  • Weight: 1.5 Pound
  • Height: 1.25 Inch
  • Depth: 4.25 Inch
  • Width: 4.5 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598225010

No Description
CLINICOMP INTERNATIONAL, INC.
4K 55
In Commercial Distribution

  • B321598225010 ()

  • Weight: 6.5 Pound
  • Width: 2.75 Inch
  • Height: 10 Inch
  • Length: 10 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598223020

No Description
CLINICOMP INTERNATIONAL, INC.
t5745
In Commercial Distribution

  • B321598223020 ()

  • Weight: 3.5 Pound
  • Width: 1.5 Inch
  • Length: 9 Inch
  • Height: 10 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598223010

No Description
CLINICOMP INTERNATIONAL, INC.
t5545
In Commercial Distribution

  • B321598223010 ()

  • Weight: 3.5 Pound
  • Depth: 9 Inch
  • Height: 8 Inch
  • Width: 2 Inch


  • Centralized patient monitor

Fetal Monitor Remote Display - B321598221010020

No Description
CLINICOMP INTERNATIONAL, INC.
ETCX X98-1 (CM9)
In Commercial Distribution

  • B321598221010020 ()

  • Width: 12 Inch
  • Height: 2 Inch
  • Length: 12 Inch
  • Weight: 5.5 Pound


  • Centralized patient monitor

Universal Data Acquisition System - B321598107300

No Description
CLINICOMP INTERNATIONAL, INC.
UDAS17
In Commercial Distribution

  • B321598107300 ()

  • Weight: 1.13 Pound
  • Depth: 1.875 Inch
  • Height: 4.5 Inch
  • Width: 8.25 Inch


  • Centralized patient monitor

Mediblu - B632MDB01035

No Description
MEDIBLU MEDICAL LLC
Blu15+
In Commercial Distribution

  • B632MDB01035 ()
MDB01035

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01034

No Description
MEDIBLU MEDICAL LLC
BLU 12+
In Commercial Distribution

  • B632MDB01034 ()
MDB01034

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01028

No Description
MEDIBLU MEDICAL LLC
BLU 12
In Commercial Distribution

  • B632MDB01028 ()
MDB01028

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01004

No Description
MEDIBLU MEDICAL LLC
MM5
In Commercial Distribution

  • B632MDB01004 ()
MDB01004

  • Multiple vital physiological parameter monitoring system, clinical

QVCAD System Installation Kit - B630QVCSIK1202346

Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010344

Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System Installation Kit - B630QVCSIK1010343

Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution

  • B630QVCSIK1010343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS346

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS344

Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS343

No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution

  • B630QVCS343 ()


  • Ultrasound imaging system application software

QVCAD System - B630QVCS342

No Description
QVIEW MEDICAL
3.4.2
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS34

No Description
QVIEW MEDICAL
3.4
In Commercial Distribution



  • Ultrasound imaging system application software

QVCAD System - B630QVCS33

No Description
QVIEW MEDICAL
3.3
In Commercial Distribution

  • B630QVCS33 ()


  • Ultrasound imaging system application software

Omni™ Surgical Suite Platform - 00889024647343

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024647343 ()
AI1000

  • Medical image management system

Omni™ Surgical Suite - 00889024624887

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1019
In Commercial Distribution

  • 00889024624887 ()
AI1019

  • Medical image management system

Omni™ Surgical Suite Platform - 00889024596184

No Description
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
AI1000
In Commercial Distribution

  • 00889024596184 ()
AI1000

  • Medical image management system

Visualize:Vascular - B725INITVV12

Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software

Mediblu - B632MDB01007

No Description
MEDIBLU MEDICAL LLC
FM10
In Commercial Distribution

  • B632MDB01007 ()
MDB01007

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01005

No Description
MEDIBLU MEDICAL LLC
MM3
In Commercial Distribution

  • B632MDB01005 ()
MDB01005

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01003

No Description
MEDIBLU MEDICAL LLC
MM12
In Commercial Distribution

  • B632MDB01003 ()
MDB01003

  • Multiple vital physiological parameter monitoring system, clinical

Mediblu - B632MDB01002

No Description
MEDIBLU MEDICAL LLC
MM15
In Commercial Distribution

  • B632MDB01002 ()
MDB01002

  • Multiple vital physiological parameter monitoring system, clinical
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