Kestra Provided Device Patient Application 80740-001

GUDID 00840241600382

ASSURE Patient Application for the Kestra Provided Device.

Kestra Medical Technologies, Inc.

Medical equipment clinical data interfacing software

• Primary Device ID: 00840241600382
• NIH Device Record Key: 895b5640-6828-492f-b17c-bf893a639667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kestra Provided Device Patient Application
• Version Model Number: 80740-001
• Catalog Number: 80740-001
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840241600382 [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: 2024-09-26
• Device Publish Date: 2024-09-18

On-Brand Devices [Kestra Provided Device Patient Application]

• 00840241600382: ASSURE Patient Application for the Kestra Provided Device.
• 00840241600399: ASSURE Patient Application for the Kestra Provided Device.