Everlywell FIT Kit

GUDID G7326001

Everly Health, Inc.

Faecal specimen collection kit IVD, home-use

• Primary Device ID: G7326001
• NIH Device Record Key: e249513d-fa07-44e2-9603-b4f173b41fba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everlywell FIT 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	G7326001 [Primary]

FDA Product Code

• NNK: Container, Specimen Mailer And Storage, Non-Sterile

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

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