IQLung 52

GUDID G29252130

Sample Collection Kit

Biodesix, Inc.

Blood collection set, invasive

• Primary Device ID: G29252130
• NIH Device Record Key: 28a5d5bb-043f-49c7-9769-e64b41287daa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQLung
• Version Model Number: 13
• Catalog Number: 52
• 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	G29252130 [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]

• G292520: Sample Collection Kit
• G29252130: Sample Collection Kit