ASSURE, Garment, Style B, Size 5 80016-005

GUDID 00840241600160

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.

Wearable defibrillation system defibrillator

• Primary Device ID: 00840241600160
• NIH Device Record Key: 64622f6b-8261-4f3b-bcce-c6a774fcae31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE, Garment, Style B, Size 5
• Version Model Number: 80016-005
• Catalog Number: 80016-005
• 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: true
• 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

Customer Support Contacts

• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx
• Phone: 1.833.692.7787
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00840241600160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200037

FDA Product Code

• MVK: Wearable Automated External Defibrillator

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-11-15

Devices Manufactured by Kestra Medical Technologies, Inc.

• 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.