Everlywell Blood Collection Kit

Basic Information

• Brand Name: Everlywell Blood Collection Kit
• Primary DI: G7321071
• Version / Model: 3
• Company Name: Everly Health, Inc.
• Labeler DUNS: 125739457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-14
• Public Version: 3
• Public Version Date: 2025-06-09
• Public Version Status: Update
• Public Device Record Key: c8508a43-562d-4198-84c1-afb99880125a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38092	Capillary blood collection set, home-use	A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory); some types may be in the form of a self-contained unit featuring a suction mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G7321071	HIBCC