CareSens S

GUDID 20385540109753

CareSens S Control Solution

AGAMATRIX, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 20385540109753
• NIH Device Record Key: 7363b7d3-c87f-4ce6-8987-6bbca656c3d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSens S
• Version Model Number: 8000-10975
• Company DUNS: 156756129
• Company Name: AGAMATRIX, INC.
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385540109759 [Primary]
GS1	20385540109753 [Package]; Contains: 00385540109759; Package: Shipper [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180866

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: 2025-08-12
• Device Publish Date: 2025-08-04

On-Brand Devices [CareSens S]

• 00385540109742: CareSens S Test Strip 50ct Vial
• 20385540109753: CareSens S Control Solution