AgaMatrix N/A

GUDID 20385541971014

Lancets, AgaMatrix, 100CT, 33Gauge

AgaMatrix, Inc.

Blood lancing device tip

• Primary Device ID: 20385541971014
• NIH Device Record Key: 8a9b250c-8817-4a43-8c18-598090f928aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AgaMatrix
• Version Model Number: 8000-01971
• Catalog Number: N/A
• Company DUNS: 156756129
• Company Name: AgaMatrix, Inc.
• Device Count: 100
• 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: 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	00385541971010 [Primary]
GS1	20385541971014 [Package]; Contains: 00385541971010; Package: Shipper [20 Units]; In Commercial Distribution
GS1	30385541971011 [Package]; Package: Outer Shipper [10 Units]; In Commercial Distribution
GS1	80385541971016 [Unit of Use]

FDA Product Code

• QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-23
• Device Publish Date: 2023-01-06

On-Brand Devices [AgaMatrix]

• 20385544940017: System Kit, Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL
• 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
• 10385544063016: Blood Glucose Meter, Agamatrix, AMP, mg/dL
• 30385544036014: Test Strips, AgaMatrix, AMP, 50CT
• 10385543909018: Blood Glucose Meter, AgaMatrix, Presto (Pillow), mg/dL
• 30385543337013: Test Strips, AgaMatrix, Presto, 50CT
• 20385542011016: Control Solution, AgaMatrix, High
• 10385541335017: Control Solution, AgaMatrix, Normal
• 20385541003401: Control Solution, AgaMatrix, Level 4
• 20385541003203: Control Solution, AgaMatrix, Level 2
• 30385541001602: Test Strips, AgaMatrix, Presto, 10CT
• 20385541971014: Lancets, AgaMatrix, 100CT, 33Gauge
• 20385541833015: Lancets, AgaMatrix, 100CT, 28Gauge