Primary Device ID | 00840241600030 |
NIH Device Record Key | 6e3e421b-96e6-46bb-8ad1-b724113ab6b4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASSURE, Monitor |
Version Model Number | 80008-003 |
Catalog Number | 80008-003 |
Company DUNS | 060944361 |
Company Name | Kestra Medical Technologies, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
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 |
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 | |
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 | 00840241600030 [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 |
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. |
00840241600276 - CareStation Server | 2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view. |
00840241600290 - CareStation Server | 2023-02-20 CareStation Server acquires and displays data from the WCD for clinicians to view. |
00840241600252 - ASSURE Patient Application | 2022-07-04 ASSURE patient app is a component of CareStation. |
00840241600269 - CareStation Server | 2022-06-21 CareStation Server acquires and displays data from the WCD for clinicians to view. |
00840241600009 - ASSURE, Battery | 2021-11-23 A rechargeable battery that powers the ASSURE System |