ASSURE Patient Application 80315-005

GUDID 00840241600214

ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStation

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software

• Primary Device ID: 00840241600214
• NIH Device Record Key: 852745bc-a423-4176-939b-5c1864970584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASSURE Patient Application
• Version Model Number: 80315-005
• Catalog Number: 80315-005
• Company DUNS: 060944361
• Company Name: Kestra Medical Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840241600214 [Primary]

FDA Product Code

• OUG: Medical Device Data System

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: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [ASSURE Patient Application]

• 00840241600214: ASSURE patient app is a component of the ASSURE WCD System and transmits information to CareStat
• 00840241600252: ASSURE patient app is a component of CareStation.
• 00840241600283: ASSURE patient app is a component of CareStation.