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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The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U502
In Commercial Distribution

  • 00855913001824 ()
U502

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients. Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings. Mattresses contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.
AUGUSTINE TEMPERATURE MANAGEMENT LLC
U501
In Commercial Distribution

  • 00855913001817 ()
U501

  • Electric pad whole-body heating system
  • Electrosurgical return electrode, reusable
No Description
FLEXICARE MEDICAL LIMITED
038-31-748U
In Commercial Distribution

  • 05055788711964 ()


  • Heated respiratory humidifier
  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-31-768U
In Commercial Distribution

  • 05055788711957 ()


  • Ventilator breathing circuit, single-use
  • Heated respiratory humidifier
No Description
FLEXICARE MEDICAL LIMITED
038-35-963U
In Commercial Distribution

  • 05055788709664 ()


  • Heated respiratory humidifier
  • Ventilator breathing circuit, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-35-964U
In Commercial Distribution

  • 05055788709657 ()


  • Ventilator breathing circuit, single-use
  • Heated respiratory humidifier
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
ELETTRONICA PAGANI SRL
STAR PLUS
In Commercial Distribution

  • 08056590170588 ()


  • Multi-modality physical therapy system, professional-use
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
ELETTRONICA PAGANI SRL
STAR
In Commercial Distribution

  • 08056590170571 ()


  • Multi-modality physical therapy system, professional-use
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
ELETTRONICA PAGANI SRL
NEVEFACE
In Commercial Distribution

  • 08056590170557 ()


  • Multi-modality physical therapy system, professional-use
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
ELETTRONICA PAGANI SRL
NEVESKIN
In Commercial Distribution

  • 08056590170540 ()


  • Multi-modality physical therapy system, professional-use
Cold and hot generator for skin cooling and heating in minor pain and skin imperfections.
ELETTRONICA PAGANI SRL
CRYO T-SHOCK 4.0
In Commercial Distribution

  • 08056590170441 ()


  • Multi-modality physical therapy system, professional-use
SET W/ LUER LOCKING CONNECTIONS, W/ UNBONDED TUBING FOR HEATING, Peritoneal Dialysis Set for Neonates
UTAH MEDICAL PRODUCTS, INC.
Set
In Commercial Distribution

  • H67140005370 ()
4000537

  • Peritoneal dialysis system tubing set
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051520021145 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08051520019623 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08051520017063 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051520016042 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051520012846 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08051520012693 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051520012686 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051160657520 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08051160654888 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08051160654499 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051160654352 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051160654284 ()
ID 300/1

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08051160651320 ()
ID 300/1

  • General-purpose drying cabinet
The SCULPT is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116H1
In Commercial Distribution

  • 08057017760719 ()
M116H1

  • Microwave hyperthermia system applicator, extracorporeal
The NEAUVIA CELL is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116I1
In Commercial Distribution

  • 08057017760511 ()
M116I1

  • Microwave hyperthermia system applicator, extracorporeal
The TIAC II is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116H1
In Commercial Distribution

  • 08057017760436 ()
M116H1

  • Microwave hyperthermia system applicator, extracorporeal
The TIAC 1 is a medical device that used high frequency RF currents to produce a localized increase in temperature in subcutaneous tissue, for temporary relief of pain and muscle spasm and increase local circulation. The device has integrated massaging handpieces intended to provide a temporary reduction in the appearance of cellulite.
EL.EN. SPA
M116E1
In Commercial Distribution

  • 08057017760405 ()
M116E1

  • Microwave hyperthermia system applicator, extracorporeal
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08058341874233 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/2
In Commercial Distribution

  • 08058341871126 ()
ID 300/2

  • General-purpose drying cabinet
This device drying cabinet provides fast drying of instruments, equipment and general item. Items are stored in controlled environment.
STEELCO SPA
ID 300/1
In Commercial Distribution

  • 08058341871119 ()
ID 300/1

  • General-purpose drying cabinet
Airvo 3 NIV Respiratory Support Device
FISHER & PAYKEL HEALTHCARE LIMITED
PT311US
In Commercial Distribution

  • 09420012466679 ()
PT311US

  • Professional BPAP/high-flow respiratory unit
3M™ Bair Paws® Patient Warming Unit, Model 895, 120V-ENG-E, Refurbished 89500
3M COMPANY
89500
Not in Commercial Distribution

  • 00608223895009 ()
89500

  • External circulating-air core temperature regulation system control unit, heating/cooling
3M™ Bair Hugger® Patient Warming Unit, Model 775, 120V-ENG-E 77533
3M COMPANY
77533
In Commercial Distribution

  • 00608223775332 ()
77533

  • External circulating-air core temperature regulation system control unit, heating/cooling
3M™ Bair-Hugger® Temperature Test Unit 22110
3M COMPANY
22110
In Commercial Distribution

  • 00608223221105 ()
22110

  • External circulating-air core temperature regulation system control unit, heating/cooling
3M™ Bair Paws® Patient Warming Unit, Model 875, 120V-ENG-E 87500
3M COMPANY
87500
In Commercial Distribution

  • 00608223875001 ()
87500

  • External circulating-air core temperature regulation system control unit, heating/cooling
3M™ Bair Hugger® Patient Warming Unit, Model 795, 120V-ENG-E, Refurbished 79500
3M COMPANY
79500
Not in Commercial Distribution

  • 00608223795002 ()
79500

  • External circulating-air core temperature regulation system control unit, heating/cooling
3M™ Bair Hugger® Patient Warming Unit, Model 775, 120V-ENG-E 77500
3M COMPANY
77500
In Commercial Distribution

  • 00608223775004 ()
77500

  • External circulating-air core temperature regulation system control unit, heating/cooling
SKIN IQ 365, POWER SUPPLY - 4 UNITS
Arjohuntleigh AB
SIQPSRU04UN
In Commercial Distribution

  • 05055982783248 ()


  • External circulating-air core temperature regulation system control unit, heating/cooling
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