Capillary Blood Specimen Collection Supplemental Pack

Basic Information

• Brand Name: Capillary Blood Specimen Collection Supplemental Pack
• Primary DI: G29259080
• Version / Model: 8
• Catalog Number: 59
• Company Name: Biodesix, Inc.
• Labeler DUNS: 809047215
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-10
• Public Version: 1
• Public Version Date: 2026-02-18
• Public Version Status: New
• Public Device Record Key: 85c7eb1b-9439-4bc5-83eb-2bbc7154fe76

Device Description

Capillary blood specimen collection pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
65859	Capillary blood collection set, professional	A collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G29259080	HIBCC
Previous	G29259070	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius