IQLung (PR) 55

GUDID G29255080

Sample Collection Kit

Biodesix, Inc.

Blood collection set, invasive

• Primary Device ID: G29255080
• NIH Device Record Key: 25d7178f-4207-46d5-ae4d-ec877e1170ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQLung (PR)
• Version Model Number: 8
• Catalog Number: 55
• Company DUNS: 809047215
• Company Name: Biodesix, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	G29255080 [Primary]

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: 2025-05-14
• Device Publish Date: 2025-05-06

On-Brand Devices [IQLung (PR)]

• G292550: Sample Collection Kit
• G29255080: Sample Collection Kit