CareSens S Fit BT

GUDID 10385540109732

CareSens S Fit BT BGM

AgaMatrix, Inc.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10385540109732
• NIH Device Record Key: 647dc424-f792-493a-b27f-d1b66c89561b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CareSens S Fit BT
• Version Model Number: 8000-10973
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com
• Phone: 1-800-880-3034
• Email: customerservice@agamatrix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385540109735 [Package]; Package: Retail [1 Units]; In Commercial Distribution
GS1	10385540109732 [Primary]
GS1	20385540109739 [Package]; Contains: 00385540109735; Package: Shipper [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193590

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: 2025-12-08
• Device Publish Date: 2025-11-30

Devices Manufactured by AgaMatrix, Inc.

• 10385540109732 - CareSens S Fit BT: 2025-12-08CareSens S Fit BT BGM
• 10385540109732 - CareSens S Fit BT: 2025-12-08 CareSens S Fit BT BGM
• 20385541833015 - AgaMatrix: 2025-09-23 Lancets, AgaMatrix, 100CT, 28Gauge
• 20385541971014 - AgaMatrix: 2025-09-23 Lancets, AgaMatrix, 100CT, 33Gauge
• 30385541001602 - AgaMatrix: 2025-09-23 Test Strips, AgaMatrix, Presto, 10CT
• 20385541003203 - AgaMatrix: 2025-09-23 Control Solution, AgaMatrix, Level 2
• 20385541003401 - AgaMatrix: 2025-09-23 Control Solution, AgaMatrix, Level 4
• 10385541335017 - AgaMatrix: 2025-09-23 Control Solution, AgaMatrix, Normal
• 20385542011016 - AgaMatrix: 2025-09-23 Control Solution, AgaMatrix, High