LEVL KIT004

GUDID G338KIT0041

This is the LEVL Starter package.

Medamonitor, LLC

Breath ketone IVD, kit, colorimetric, rapid

• Primary Device ID: G338KIT0041
• NIH Device Record Key: eeafb491-6cdc-40e8-8c6b-e5e944dd4e07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEVL
• Version Model Number: 1
• Catalog Number: KIT004
• Company DUNS: 044324634
• Company Name: Medamonitor, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com
• Phone: 833-5385669
• Email: questions@levlnow.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G338KIT0041 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2022-09-21
• Device Publish Date: 2022-09-13