Primary Device ID | 00840241600016 |
NIH Device Record Key | 3f92465c-4c29-45c4-85f3-3b179db8a2be |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASSURE, Charger |
Version Model Number | 3326633-004 |
Catalog Number | 3326633-004 |
Company DUNS | 060944361 |
Company Name | Kestra Medical Technologies, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
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Phone | 1.833.692.7787 |
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Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx | |
Phone | 1.833.692.7787 |
xx@xx.xx |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840241600016 [Primary] |
MVK | Wearable Automated External Defibrillator |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-11-23 |
Device Publish Date | 2021-11-15 |
00840241600313 - ASSURE Wearable ECG | 2024-09-26 A wearable cardiac episode recorder |
00840241600320 - Battery | 2024-09-26 A rechargeable battery that powers the ASSURE Wearable ECG |
00840241600337 - System Cable | 2024-09-26 Provides the connection between an ASSURE Garment and a Battery |
00840241600344 - ASSURE Assist Service | 2024-09-26 The Event Response System (ERS) is a software-only powered communication system that informs a remote user responder of the occu |
00840241600382 - Kestra Provided Device Patient Application | 2024-09-26 ASSURE Patient Application for the Kestra Provided Device. |
00840241600238 - ASSURE WCD System | 2023-07-04 The ASSURE Wearable Cardioverter Defibrillator System |
00840241600283 - ASSURE Patient Application | 2023-03-21 ASSURE patient app is a component of CareStation. |
00840241600306 - CareStation Server | 2023-03-20 CareStation Server acquires and displays data from the WCD for clinicians to view. |