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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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The ASSURE Wearable Cardioverter Defibrillator System
Kestra Medical Technologies, Inc.
80014-002
In Commercial Distribution

80014-002

  • Wearable defibrillation system defibrillator
A part of the ASSURE System that provides power and displays system status information
Kestra Medical Technologies, Inc.
80008-004
In Commercial Distribution

80008-004

  • Wearable defibrillation system defibrillator
A portable case that holds the Monitor while wearing the ASSURE system
Kestra Medical Technologies, Inc.
3326502-003
In Commercial Distribution

  • 00840241600207 ()
3326502-003

  • Wearable defibrillation system defibrillator
An electronic device used to program the ASSURE system and assist in patient fitting and training
Kestra Medical Technologies, Inc.
80041-001
In Commercial Distribution

  • 00840241600191 ()
80041-001

  • Wearable defibrillation system defibrillator
The Style B, Size 7, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-007
In Commercial Distribution

  • 00840241600184 ()

  • Style B, Size 7
80016-007

  • Wearable defibrillation system defibrillator
The Style B, Size 6, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-006
In Commercial Distribution

  • 00840241600177 ()

  • Style B, Size 6
80016-006

  • Wearable defibrillation system defibrillator
The Style B, Size 5, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-005
In Commercial Distribution

  • 00840241600160 ()

  • Style B, Size 5
80016-005

  • Wearable defibrillation system defibrillator
The Style B, Size 4, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-004
In Commercial Distribution

  • 00840241600153 ()

  • Style B, Size 4
80016-004

  • Wearable defibrillation system defibrillator
The Style B, Size 3, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-003
In Commercial Distribution

  • 00840241600146 ()

  • Style B, Size 3
80016-003

  • Wearable defibrillation system defibrillator
The Style B, Size 2, ASSURE Garment is a fabric top that contains Sensors that track heart rhythm. It is worn directly on the body against bare skin.
Kestra Medical Technologies, Inc.
80016-002
In Commercial Distribution

  • 00840241600139 ()

  • Style B, Size 2
80016-002

  • Wearable defibrillation system defibrillator
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