Everlywell Urine Collection Kit

GUDID G7324001

Everly Health, Inc.

Urine specimen collection kit IVD

• Primary Device ID: G7324001
• NIH Device Record Key: b7642d92-2599-4d6e-9afc-ba517f3efc7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everlywell Urine Collection Kit
• Version Model Number: 1
• 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	G7324001 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

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: 2025-02-24
• Device Publish Date: 2025-02-14

On-Brand Devices [Everlywell Urine Collection Kit]

• G7324011: 1
• G7324001: 1