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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A40 ProEFL, System One Heated Tube Humidifier, Benelux
Respironics, Inc.
BLX3T
In Commercial Distribution

  • 00606959058538 ()
BLX3T

  • Heated respiratory humidifier
Hum, A Series, Sys One, Flow Gen, CN
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061958 ()
1147250

  • Heated respiratory humidifier
DreamStation Humidifier, International
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061040 ()
INXH

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, Italy
Respironics, Inc.
ITX3T
In Commercial Distribution

  • 00606959058545 ()
ITX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, Nordic
Respironics, Inc.
NDX3T
In Commercial Distribution

  • 00606959058521 ()
NDX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, France
Respironics, Inc.
FRX3T
In Commercial Distribution

  • 00606959058514 ()
FRX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, Iberia
Respironics, Inc.
ESX3T
In Commercial Distribution

  • 00606959058507 ()
ESX3T

  • Heated respiratory humidifier
A40 ProEFL, System One Heated Tube Humidifier, United Kingdom
Respironics, Inc.
GBX3T
In Commercial Distribution

  • 00606959058491 ()
GBX3T

  • Heated respiratory humidifier
A40 ProEFL, System One HeatedTube Humidifier, Germany
Respironics, Inc.
DEX3T
In Commercial Distribution

  • 00606959058484 ()
DEX3T

  • Heated respiratory humidifier
No Description
EMIT CORPORATION
FA100004
In Commercial Distribution

  • 00850003277042 ()
  • 00850003277073 ()
  • 00850003277066 ()
  • 00850003277059 ()
  • 00850003277097 ()
  • 00850003277080 ()


  • Conduction blood/fluid warmer
No Description
EMIT CORPORATION
FA100001
In Commercial Distribution

  • 00850003277035 ()
  • 00850003277004 ()
  • 00850003277011 ()
  • 00850003277028 ()
  • 00850003277110 ()
  • 00850003277103 ()


  • Conduction blood/fluid warmer
Kelvi Hip Pro Smart Wrap, Right
HYPOTHERMIA DEVICES, INC.
KLV20009
In Commercial Distribution

  • 00850001185110 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hip Pro Smart Wrap, Left
HYPOTHERMIA DEVICES, INC.
KLV20008
In Commercial Distribution

  • 00850001185103 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Hand Station
HYPOTHERMIA DEVICES, INC.
KLV20005
In Commercial Distribution

  • 00850001185073 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Ankle Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20004
In Commercial Distribution

  • 00850001185059 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Knee Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20003
In Commercial Distribution

  • 00850001185042 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Back Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20002
In Commercial Distribution

  • 00850001185035 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Shoulder Pro Smart Wrap
HYPOTHERMIA DEVICES, INC.
KLV20001
In Commercial Distribution

  • 00850001185028 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Umbilical
HYPOTHERMIA DEVICES, INC.
KLV40001
In Commercial Distribution

  • 00850001185011 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Console
HYPOTHERMIA DEVICES, INC.
KLV10001
In Commercial Distribution

  • 00850001185004 ()


  • Circulating-fluid localized thermal therapy system
Distal Phasitron, Case of 5 Phasitrons
PERCUSSIONAIRE CORPORATION
S20020
In Commercial Distribution

  • 10849436000690 ()
  • 00849436000693 ()
S20020

  • Ventilator breathing circuit, single-use
Phasitron 5 With Unified Connector
PERCUSSIONAIRE CORPORATION
P5
In Commercial Distribution

  • 10849436000683 ()
  • 00849436000686 ()
P5-UC

  • Ventilator breathing circuit, single-use
TXP5 Phasitron Kit - Pack of 5
PERCUSSIONAIRE CORPORATION
A50606-TXP
Not in Commercial Distribution

  • 10849436000614 ()
  • 00849436000617 ()
A50606-TXP

  • Ventilator breathing circuit, single-use
IPV Phasitron Breathing Circuit Kit, Single Patient, Travel Air Phasitron 5
PERCUSSIONAIRE CORPORATION
P5-TA
Not in Commercial Distribution

  • 20849436000536 ()
  • 00849436000532 ()
  • 10849436000539 ()
P5-TA

  • Ventilator breathing circuit, single-use
IPV Phasitron Breathing Circuit Kit, Single Patient, HC Phasitron 5
PERCUSSIONAIRE CORPORATION
P5-HC
In Commercial Distribution

  • 10849436000522 ()
  • 00849436000525 ()
P5-HC

  • Ventilator breathing circuit, single-use
IPV Phasitron Breathing Circuit Kit, Single Patient, Therapy Phasitron 5
PERCUSSIONAIRE CORPORATION
P5-TH
Not in Commercial Distribution

  • 00849436000518 ()
  • 10849436000515 ()
P5-TH

  • Ventilator breathing circuit, single-use
IPV Phasitron Breathing Circuit Kit, Single Patient, Hospital Phasitron 5
PERCUSSIONAIRE CORPORATION
P5
In Commercial Distribution

  • 10849436000508 ()
  • 00849436000501 ()
P5

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV HC, DM, Single Patient
PERCUSSIONAIRE CORPORATION
A50110-HC-DM
Not in Commercial Distribution

  • 00849436000488 ()
A50110-HC-DM

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV, Single Patient, with Failsafe Band
PERCUSSIONAIRE CORPORATION
A50095-F
Not in Commercial Distribution

  • 00849436000464 ()
  • 10849436000461 ()
A50095-F

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV HC, Home Care Duo (New name for A50110-HC. Same product.)
PERCUSSIONAIRE CORPORATION
A50110-HC-DUO
Not in Commercial Distribution

  • 00849436000457 ()
A50110-HC-DUO

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV HC-1D, Single Patient (New name for A50110-HC-OP A-D, same product.)
PERCUSSIONAIRE CORPORATION
A50110-HC-1D
Not in Commercial Distribution

  • 00849436000433 ()
A50110-HC-1D

  • Ventilator breathing circuit, single-use
Phasitron Kit, Impulsator Travel Air, Single Patient
PERCUSSIONAIRE CORPORATION
A55108
Not in Commercial Distribution

  • 10849436000348 ()
  • 00849436000341 ()
a55108

  • Ventilator breathing circuit, single-use
Phasitron Kit, HF Transport, Single Patient
PERCUSSIONAIRE CORPORATION
A50605-D
In Commercial Distribution

  • 10849436000331 ()
  • 00849436000334 ()
A50605-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV/CMV, Single Patient
PERCUSSIONAIRE CORPORATION
A50474-2D
Not in Commercial Distribution

  • 10849436000324 ()
  • 00849436000327 ()
A50474-2D

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV HC Option A, Single Patient
PERCUSSIONAIRE CORPORATION
A50110-HC-OP A-D
Not in Commercial Distribution

  • 00849436000310 ()
A50110-HC-OP A-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV HC, Home Care Duo
PERCUSSIONAIRE CORPORATION
A50110-HC
Not in Commercial Distribution

  • 00849436000303 ()
A50110-HC

  • Ventilator breathing circuit, single-use
Phasitron Kit, VDR, Turbo Hub, Single Patient
PERCUSSIONAIRE CORPORATION
A50096-D
Not in Commercial Distribution

  • 00849436000297 ()
  • 10849436000294 ()
A50096-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV with Phasitron Duo
PERCUSSIONAIRE CORPORATION
A50095-DUO
Not in Commercial Distribution

  • 00849436000280 ()
A50095-DUO

  • Ventilator breathing circuit, single-use
Phasitron Kit, IPV, Single Patient
PERCUSSIONAIRE CORPORATION
A50095-D
Not in Commercial Distribution

  • 10849436000270 ()
  • 00849436000273 ()
A50095-D

  • Ventilator breathing circuit, single-use
Phasitron Kit, Single Patient, IPV w/button
PERCUSSIONAIRE CORPORATION
A50095-1D
Not in Commercial Distribution

  • 00849436000266 ()
A50095-1D

  • Ventilator breathing circuit, single-use
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