IQLung (PR) 55

GUDID G292550

Sample Collection Kit

Biodesix, Inc.

Blood collection set, invasive

• Primary Device ID: G292550
• NIH Device Record Key: f8464add-9c46-4da4-b76e-8d39241059c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQLung (PR)
• Version Model Number: 2
• Catalog Number: 55
• Company DUNS: 809047215
• Company Name: Biodesix, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	G292550 [Primary]

FDA Product Code

• PQD: Blood Specimen Collection Convenience Kit (Excludes Hiv)

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: 2023-03-16
• Device Publish Date: 2023-03-08

Devices Manufactured by Biodesix, Inc.

• G292570 - Hibercell PAN2111: 2023-10-31 Sample Collection Kit
• G292590 - Capillary Blood Specimen Collection Supplemental Pack: 2023-08-04 Capillary blood collection kit, professional
• G292510 - Nodify Lung: 2023-03-16 Sample collection kit
• G292520 - IQLung: 2023-03-16 Sample Collection Kit
• G292550 - IQLung (PR): 2023-03-16Sample Collection Kit
• G292550 - IQLung (PR): 2023-03-16 Sample Collection Kit
• G292560 - Nodify Lung (PR): 2023-03-16 Sample Collection Kit