Everlywell Blood and Urine Collection Kit

GUDID G7327021

Everly Health, Inc.

Urine specimen collection kit IVD

• Primary Device ID: G7327021
• NIH Device Record Key: 4c8747cb-3767-4a4c-9f7d-82ad98cae789
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everlywell Blood and Urine Collection Kit
• Version Model Number: 2
• Company DUNS: 125739457
• Company Name: Everly Health, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	G7327021 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-06-06
• Device Publish Date: 2025-02-18

Devices Manufactured by Everly Health, Inc.

• G7327021 - Everlywell Blood and Urine Collection Kit: 2025-06-06
• G7327021 - Everlywell Blood and Urine Collection Kit: 2025-06-06
• G7321001 - Everlywell Blood Collection Kit: 2025-02-24
• G7321011 - Everlywell Blood Collection Kit: 2025-02-24
• G7321021 - Everlywell Blood Collection Kit: 2025-02-24
• G7321031 - Everlywell Blood Collection Kit: 2025-02-24
• G7321041 - Everlywell Blood Collection Kit: 2025-02-24
• G7321061 - Everlywell Blood Collection Kit: 2025-02-24
• G7321071 - Everlywell Blood Collection Kit: 2025-02-24