AgaMatrix 8000-10878

GUDID 10385541000700

Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL

AGAMATRIX, INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 10385541000700
• NIH Device Record Key: a2ac0e6e-56ab-4ebb-a6dd-5c39bccca301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AgaMatrix
• Version Model Number: 8000-04094
• Catalog Number: 8000-10878
• 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: false
• 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: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10385541000700 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-12-30
• Device Publish Date: 2016-11-04

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• 20385541000806: System Kit, Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL
• 10385542661016: Blood Glucose Meter, AgaMatrix, Presto, mg/dL
• 10385541000700: Blood Glucse Meter, Agamatrix, Presto PRO, mg/dL