Nodify 51

GUDID G29251110

Sample Collection Kit

Biodesix, Inc.

Blood collection set, invasive

• Primary Device ID: G29251110
• NIH Device Record Key: 52604e33-878d-4bf8-af1b-0d8d26959377
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nodify
• Version Model Number: 11
• Catalog Number: 51
• 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	G29251110 [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: 2025-05-15
• Device Publish Date: 2025-05-07

Devices Manufactured by Biodesix, Inc.

• G29251110 - Nodify: 2025-05-15Sample Collection Kit
• 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
• G292520 - IQLung: 2023-03-16 Sample Collection Kit
• G292550 - IQLung (PR): 2023-03-16 Sample Collection Kit