AgaMatrix

GUDID 10385541002001

Test Strips, AgaMatrix, Jazz, 10CT

AGAMATRIX, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 10385541002001
• NIH Device Record Key: 52031f67-b45b-47a6-aa46-c11f53ed8dae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AgaMatrix
• Version Model Number: 8000-10474
• Company DUNS: 156756129
• Company Name: AGAMATRIX, INC.
• Device Count: 10
• 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: true
• 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

Customer Support Contacts

• Phone: 18669064197
• Email: customerservice@agamatrix.com
• Phone: 18669064197
• Email: customerservice@agamatrix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385541001908 [Primary]
GS1	10385541002001 [Package]; Contains: 00385541001908; Package: Shipper [24 Units]; In Commercial Distribution
GS1	20385541002909 [Package]; Package: Outer Shipper [20 Units]; In Commercial Distribution
GS1	80385541001904 [Unit of Use]

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: 4
• Public Version Date: 2018-12-03
• Device Publish Date: 2016-07-11

On-Brand Devices [AgaMatrix]

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• 00385544025017: System Kit, Blood Glucose Meter, Agamatrix, AMP, mg/dL
• 20385543764027: Control Solution, AgaMatrix, Combo Normal and High
• 20385542649011: System Kit, Blood Glucose Meter, AgaMatrix, Presto, mg/dL
• 10385541002605: System Kit, Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL
• 00385541002509: Blood Glucse Meter, AgaMatrix, Jazz Wireless 2, mg/dL
• 10385541002407: Test Strips, AgaMatrix, Jazz, 50CT
• 10385541002001: Test Strips, AgaMatrix, Jazz, 10CT
• 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