Nodify (PR) 56

GUDID G29256080

Sample Collection Kit

Biodesix, Inc.

Blood collection set, invasive

• Primary Device ID: G29256080
• NIH Device Record Key: bfb30eca-338e-43dc-bfbd-968b23320071
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nodify (PR)
• Version Model Number: 8
• Catalog Number: 56
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G29256080 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-04
• Device Publish Date: 2025-05-07

Devices Manufactured by Biodesix, Inc.

• G29256080 - Nodify (PR): 2026-02-04Sample Collection Kit
• G29256080 - Nodify (PR): 2026-02-04 Sample Collection Kit
• G29259070 - Capillary Blood Specimen Collection Supplemental Pack: 2025-09-05 Capillary blood specimen collection pack
• G29251110 - Nodify: 2025-05-15 Sample Collection Kit
• G29252130 - IQLung: 2025-05-14 Sample Collection Kit
• G29255080 - IQLung (PR): 2025-05-14 Sample Collection Kit
• 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