DEVICE: ASSURE, Monitor (00840241600030)

Device Identifier (DI) Information

ASSURE, Monitor
80008-003
In Commercial Distribution
80008-003
Kestra Medical Technologies, Inc.
00840241600030
GS1

1
060944361 *Terms of Use
A part of the ASSURE System that provides power and displays system status information
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
48052 Wearable defibrillation system defibrillator
A portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MVK Wearable Automated External Defibrillator
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P200037 000
P200037 001
P200037 002
P200037 003
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6e3e421b-96e6-46bb-8ad1-b724113ab6b4
January 12, 2022
2
November 15, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1.833.692.7787
xx@xx.xx
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