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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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SOZO Body Fluid Analyzer - B27725269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Demo Device
IMPEDIMED LIMITED
2526995
In Commercial Distribution

  • B27725269950 ()
  • B27725269951 ()
  • B27725269952 ()
252-SOZO

  • Bioelectrical body composition analyser

Imp SFB7 - B277249SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW Refurbished-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277249SFB70 ()
  • B277249SFB71 ()
  • B277249SFB72 ()


  • Bioelectrical body composition analyser

Imp DF50 - B277249DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277249DF502 ()
  • B277249DF501 ()
  • B277249DF500 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277243SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US Refurbished- Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277243SFB72 ()
  • B277243SBF71 ()
  • B277243SFB70 ()
243-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277243DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US Refurbished Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277243DF502 ()
  • B277243DF501 ()
  • B277243DF500 ()
229-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277242LDEXU4000

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B277242LDEXU4002 ()
  • B277242LDEXU4001 ()
  • B277242LDEXU4000 ()
242-LDEXU400

  • Bioelectrical body composition analyser

SOZO Body Fluid Analyzer - B27724269950

SOZO Body Fluid Analyzer working in conjunction with SOZOapp is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via dry electrode, and displaying the results on a monitor. Refurbished Device
IMPEDIMED LIMITED
2426995
In Commercial Distribution

  • B27724269952 ()
  • B27724269951 ()
  • B27724269950 ()
242-SOZO

  • Bioelectrical body composition analyser

Imp SFB7 - B277229SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. ROW New-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277229SFB72 ()
  • B277229SFB71 ()
  • B277229SFB70 ()
229-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277229DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. ROW New Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277229DF502 ()
  • B277229DF501 ()
  • B277229DF500 ()
229-DF50

  • Bioelectrical body composition analyser

Imp SFB7 - B277223SFB70

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. US New-Device
IMPEDIMED LIMITED
SFB7
In Commercial Distribution

  • B277223SFB72 ()
  • B277223SFB71 ()
  • B277223SFB70 ()
223-SFB7

  • Bioelectrical body composition analyser

Imp DF50 - B277223DF500

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals. US New Device
IMPEDIMED LIMITED
DF50
Not in Commercial Distribution

  • B277223DF502 ()
  • B277223DF501 ()
  • B277223DF500 ()
223-DF50

  • Bioelectrical body composition analyser

L-Dex® U400 - B277222LDEXU4000

BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor. New-Device
IMPEDIMED LIMITED
U400
In Commercial Distribution

  • B277222LDEXU4002 ()
  • B277222LDEXU4001 ()
  • B277222LDEXU4000 ()
222-LDEXU400

  • Bioelectrical body composition analyser

Ostial Sprit Cannulae - B270CVCP040080

Ostial Perfusion Cannula
Spyder Medical
CV.CP04008
In Commercial Distribution

  • B270CVCP040082 ()
  • B270CVCP040080 ()
  • B270CVCP040081 ()
CV.CP04008

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040070

Ostial Perfusion Cannula
Spyder Medical
CV.CP04007
In Commercial Distribution

  • B270CVCP040072 ()
  • B270CVCP040070 ()
  • B270CVCP040071 ()
CV.CP04007

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040060

Ostial Perfusion Cannula
Spyder Medical
CV.CP04006
In Commercial Distribution

  • B270CVCP040062 ()
  • B270CVCP040060 ()
  • B270CVCP040061 ()
CV.CP4006

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040050

Ostial Perfusion Cannula
Spyder Medical
CV.CP04005
In Commercial Distribution

  • B270CVCP040052 ()
  • B270CVCP040050 ()
  • B270CVCP040051 ()
CV.CP04005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP040040

Ostial Perfusion Cannula
Spyder Medical
CV.CP04004
In Commercial Distribution

  • B270CVCP040042 ()
  • B270CVCP040040 ()
  • B270CVCP040041 ()
CV.CP04004

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP030080

Ostial Perfusion Cannula
Spyder Medical
CV.CP03008
In Commercial Distribution

  • B270CVCP030082 ()
  • B270CVCP030080 ()
  • B270CVCP030081 ()
CV.CP03008

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP030070

Ostial Perfusion Cannula
Spyder Medical
CV.CP03007
In Commercial Distribution

  • B270CVCP030072 ()
  • B270CVCP030070 ()
  • B270CVCP030071 ()
CV.CP03007

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannula - B270CVCP030060

Ostial Perfusion Cannula
Spyder Medical
CV.CP03006
In Commercial Distribution

  • B270CVCP030062 ()
  • B270CVCP030060 ()
  • B270CVCP030061 ()
CV.CP03006

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP030050

Ostial Sprit Cannula
Spyder Medical
CV.CP03005
In Commercial Distribution

  • B270CVCP030052 ()
  • B270CVCP030050 ()
  • B270CVCP030051 ()
CV.CP03005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP030040

Ostial Perfusion Cannulae
Spyder Medical
CV.CP03004
In Commercial Distribution

  • B270CVCP030042 ()
  • B270CVCP030040 ()
  • B270CVCP030041 ()
CV.CP03004

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP020080

Ostial Perfusion Cannula
Spyder Medical
CV.CP02008
In Commercial Distribution

  • B270CVCP020082 ()
  • B270CVCP020080 ()
  • B270CVCP020081 ()
CV.CP02008

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP020070

Ostial Perfusion Cannula
Spyder Medical
CV.CP02007
In Commercial Distribution

  • B270CVCP020072 ()
  • B270CVCP020070 ()
  • B270CVCP020071 ()
CV.CP02007

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP020060

Ostial Perfusion Cannula
Spyder Medical
CV.CP02005
In Commercial Distribution

  • B270CVCP020062 ()
  • B270CVCP020060 ()
  • B270CVCP020061 ()
CV.CP02005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP020050

Ostial Perfusion Cannula
Spyder Medical
CV.CP02005
In Commercial Distribution

  • B270CVCP020052 ()
  • B270CVCP020050 ()
  • B270CVCP020051 ()
CV.CP02005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP020040

Ostial Perfusion Cannula
Spyder Medical
CV.CP02004
In Commercial Distribution

  • B270CVCP020042 ()
  • B270CVCP020040 ()
  • B270CVCP020041 ()
CV.CP02004

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP010080

Ostial Perfusion Cannula
Spyder Medical
CV.CP01008
In Commercial Distribution

  • B270CVCP010080 ()
  • B270CVCP010082 ()
  • B270CVCP010081 ()
CV.CP01008

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP010070

Ostial Perfusion Cannula
Spyder Medical
CV.CP01007
In Commercial Distribution

  • B270CVCP010070 ()
  • B270CVCP0100702 ()
  • B270CVCP010071 ()
CV.CP01007

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP010060

Ostial Perfusion Cannula
Spyder Medical
CV.CP01006
In Commercial Distribution

  • B270CVCP010060 ()
  • B270CVCP010062 ()
  • B270CVCP010061 ()
CV.CP01006

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP010050

Ostial Perfusion Cannula
Spyder Medical
CV.CP01005
In Commercial Distribution

  • B270CVCP010050 ()
  • B270CVCP010052 ()
  • B270CVCP010051 ()
CV.CP01005

  • Vascular irrigation cannula, coronary artery, single-use

Ostial Sprit Cannulae - B270CVCP010040

Ostial Perfusion Cannulae
Spyder Medical
CV.CP01004
In Commercial Distribution

  • B270CVCP010040 ()
  • B270CVCP010042 ()
  • B270CVCP010041 ()
CV.CP01004

  • Vascular irrigation cannula, coronary artery, single-use

American Red Cross - B268Y79160

Thermometer
TOMY INTERNATIONAL, INC.
Y7916
In Commercial Distribution

  • B268Y79161 ()
  • B268Y79160 ()
  • B268Y791695 ()
Y7916

  • General-purpose patient temperature probe, reusable

American Red Cross - B268Y77900

American Red Cross Infrared non-Contact Forehead Thermometer
TOMY INTERNATIONAL, INC.
Y7790
In Commercial Distribution

  • B268Y77904 ()
  • B268Y77901 ()
  • B268Y77900 ()
Y7790

  • General-purpose patient temperature probe, reusable

The First Years - B268Y7057A51

Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7057A5
In Commercial Distribution

  • B268Y7057A51 ()
  • B268Y7057A53 ()
  • B268Y7057A59 ()
Y7057A5

  • Infant care kit

American Red Cross - B268Y108960

Ear Thermometer
TOMY INTERNATIONAL, INC.
Y10896
In Commercial Distribution

  • B268Y108964 ()
  • B268Y108961 ()
  • B268Y108960 ()
Y10896

  • General-purpose patient temperature probe, reusable

PURE ENRICHMENT - B311PETNEMPD5

Wired TENS+EMS+HEAT Replacement Gel Pads
BEAR DOWN CONSULTING
PETNEMPD5
In Commercial Distribution

  • B311PETNEMPD51 ()
  • B311PETNEMPD5 ()
  • B311PETNEMPD52 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PETNEMPD2

Wired TENS+EMS+HEAT Replacement Gel Pads 2 sets
BEAR DOWN CONSULTING
PETNEMPD2
In Commercial Distribution

  • B311PETNEMPD21 ()
  • B311PETNEMPD2 ()
  • B311PETNEMPD22 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PETNEMHT0

No Description
BEAR DOWN CONSULTING
PETNEMHT
In Commercial Distribution

  • B311PETNEMHT1 ()
  • B311PETNEMHT0 ()
  • B311PETNEMHT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

PURE ENRICHMENT - B311PEPULSERT0

No Description
BEAR DOWN CONSULTING
PEPULSE-RT
In Commercial Distribution

  • B311PEPULSERT0 ()
  • B311PEPULSERT1 ()
  • B311PEPULSERT2 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

PURE ENRICHMENT - B311PEHTNPDS50

Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS5
In Commercial Distribution

  • B311PEHTNPDS51 ()
  • B311PEHTNPDS50 ()
  • B311PEHTNPDS52 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PEHTNPDS20

Reusable electrode gel pads.
BEAR DOWN CONSULTING
PEHTNPDS2
In Commercial Distribution

  • B311PEHTNPDS21 ()
  • B311PEHTNPDS20 ()
  • B311PEHTNPDS22 ()


  • Transcutaneous electrical stimulation electrode, single-use

TheraClear - B30530TC0300

No Description
THERAVANT CORPORATION
30TC03000AA
In Commercial Distribution

  • B30530TC0300 ()
  • B30530TC0301 ()
  • B30530TC0302 ()
30TC030

  • Multi-modality skin surface treatment system generator

TheraClear - B30520TC1290

No Description
THERAVANT CORPORATION
20TC12900AA
In Commercial Distribution

  • B30520TC1290 ()
  • B30520TC1292 ()
  • B30520TC1291 ()
20TC129

  • Multi-modality skin surface treatment system generator

Rescuer 7000-AD Replacement Suction Canister kit - B0027000AD0

Replacement canister kit and catheters for 7000-MVP
B.L.S. Systems Limited
7000-AD
In Commercial Distribution

  • B0027000AD9 ()
  • B0027000AD0 ()
  • B0027000AD2 ()
7000-AD

  • Emergency airway clearance suction pump, manual

Rescuer O-Mask Oxygen Mask with Universal Tubing - B0026210U0

Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)
B.L.S. Systems Limited
6210-U
In Commercial Distribution

  • B0026210U7 ()
  • B0026210U0 ()
  • B0026210U9 ()

  • Child
6210-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Child - B00262100

O-Mask Oxygen Mask, Child
B.L.S. Systems Limited
6210
In Commercial Distribution

  • B00262107 ()
  • B00262100 ()
  • B00262109 ()

  • Child
6210

  • Non-rebreathing oxygen face mask

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult) - B0026205U0

Rescuer O-Mask with Universal Oxygen Tubing (Small Adult)
B.L.S. Systems Limited
6205-U
In Commercial Distribution

  • B0026205U7 ()
  • B0026205U0 ()
  • B0026205U9 ()

  • Small Adult
6205-U

  • Non-rebreathing oxygen face mask

O-Mask Oxygen Mask, Small Adult - B00262050

O-Mask Oxygen Mask, Small Adult
B.L.S. Systems Limited
6205
In Commercial Distribution

  • B00262057 ()
  • B00262050 ()
  • B00262059 ()

  • Small Adult
6205

  • Non-rebreathing oxygen face mask

Rescuer O-Mask - B0026200U0

Rescuer O-Mask with Universal Tubing (Large Adult)
B.L.S. Systems Limited
6200-U
In Commercial Distribution

  • B0026200U0 ()
  • B0026200U7 ()
  • B0026200U9 ()

  • Large Adult
6200-U

  • Non-rebreathing oxygen face mask
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