SureMediks B-ketone & blood glucose monitoring system

GUDID 00199284201354

Rasimo Systems LLC

Multiple clinical chemistry analyte monitoring system IVD, home-use

• Primary Device ID: 00199284201354
• NIH Device Record Key: 7f5ab1ac-9e5d-47dc-b880-fa171815a741
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureMediks B-ketone & blood glucose monitoring system
• Version Model Number: TD-4279D
• Company DUNS: 111070873
• Company Name: Rasimo Systems LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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
GS1	00199284201354 [Primary]

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

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: 2025-12-15
• Device Publish Date: 2025-12-05

Devices Manufactured by Rasimo Systems LLC

• 00199284201354 - SureMediks B-ketone & blood glucose monitoring system: 2025-12-15
• 00199284201354 - SureMediks B-ketone & blood glucose monitoring system: 2025-12-15
• 00199284689879 - SureMediks B-Ketone Test Strips (25pcs/box): 2025-12-15