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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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Extra Large Switched Internal Paddles
Philips Medical Systems Hsg
989803109731
In Commercial Distribution

  • 00884838003323 ()
M4741A

  • Internal defibrillation electrode, adult, reusable
HS Switchless Int Pdl Adapter
Philips Medical Systems Hsg
Switched Int Pdl Adapter
Not in Commercial Distribution

  • 00884838003316 ()
M4740A

  • Electrosurgical cable adaptor
HS Pedi Radiotransparent Pads
Philips Medical Systems Hsg
989803125411
In Commercial Distribution

  • 00884838002883 ()
M3719A

  • External defibrillation electrode, paediatric, single-use
HeartStart Infant Plus Pads
Philips Medical Systems Hsg
989803107821
In Commercial Distribution

  • 00884838002869 ()
M3717A

  • External defibrillation electrode, paediatric, single-use
Lithium Ion Battery Module
Philips Medical Systems Hsg
MRx Lithium Ion Battery Module
Not in Commercial Distribution

  • 00884838002791 ()
M3538A

  • Secondary battery
Additional 7-Wire Lead Set for 12 Lead (IEC)
Philips Medical Systems Hsg
7-Wire Lead Set for 12-lead use IEC
Not in Commercial Distribution

  • 00884838002784 ()
M3529A

  • Electrocardiographic lead set, reusable
3-wire lead set and plug, snap, (IEC)
Philips Medical Systems Hsg
3-Wire Lead Set and Plug Snap IEC
Not in Commercial Distribution

  • 00884838002777 ()
M3528A

  • Electrocardiographic lead set, reusable
No Description
Philips Medical Systems Hsg
989803107041
Not in Commercial Distribution

  • 00884838002760 ()
989803107041

  • Rechargeable professional automated external defibrillator
No Description
Philips Medical Systems Hsg
453564675561
In Commercial Distribution

  • 00884838002753 ()
453564675561

  • Electrosurgical cable adaptor
Small Switchless Int Pdl
Philips Medical Systems Hsg
Small Switchless Int Pdl
In Commercial Distribution

  • 00884838002111 ()
M1744A

  • Internal defibrillation electrode, adult, reusable
Medium Switchless Int Pdl
Philips Medical Systems Hsg
Medium Switchless Int Pdl
In Commercial Distribution

  • 00884838002104 ()
M1743A

  • Internal defibrillation electrode, adult, reusable
Large Switchless Int Pdl
Philips Medical Systems Hsg
Large Switchless Int Pdl
In Commercial Distribution

  • 00884838002098 ()
M1742A

  • Internal defibrillation electrode, adult, reusable
Extra Lrg Switchless Int Pdl
Philips Medical Systems Hsg
Extra Lrg Switchless Internal Paddle
In Commercial Distribution

  • 00884838002081 ()
M1741A

  • Internal defibrillation electrode, adult, reusable
HeartStart MRx monitor/defib
Philips Medical Systems Hsg
861288
Not in Commercial Distribution

  • 00884838000018 ()
M3535A

  • Rechargeable professional automated external defibrillator
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • M727SAM450P ()


  • Non-rechargeable public semi-automated external defibrillator
Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-07
In Commercial Distribution

  • M727PADPAK07 ()
Pad-Pak-07

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-02
In Commercial Distribution

  • M727PADPAK02 ()
Pad-Pak-02

  • Non-rechargeable public semi-automated external defibrillation electrode, paediatric
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
HEARTSINE TECHNOLOGIES LTD
Pad-Pak-01
In Commercial Distribution

  • M727PADPAK01 ()
Pad-Pak-01

  • Non-rechargeable public semi-automated external defibrillation electrode, adult
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-044874-00
In Commercial Distribution

  • 06944904096636 ()


  • General-purpose multi-parameter bedside monitor
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013219-00
In Commercial Distribution

  • 06944904085906 ()


  • Patient monitoring system module, multiple-gas
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013218-00
In Commercial Distribution

  • 06944904085890 ()


  • Patient monitoring system module, electroencephalographic
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013204-00
In Commercial Distribution

  • 06944904085869 ()


  • Patient monitoring system module, multiple-gas
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013203-00
In Commercial Distribution

  • 06944904085852 ()


  • Patient monitoring system module, electroencephalographic
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-013202-00
In Commercial Distribution

  • 06944904085845 ()


  • Patient monitoring system module, multiple-gas
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-001698-00
In Commercial Distribution

  • 06944904085760 ()


  • Patient monitoring system module, multiple-gas
No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-051561-00
In Commercial Distribution

  • 06944904000244 ()


  • Anaesthesia unit, mobile
No Description
Microgenics Corporation
10016417
In Commercial Distribution

  • 00884883012523 ()


  • Amphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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