AgaMatrix Lancing Device

GUDID 00385541062206

AGAMATRIX, INC.

Manual blood lancing device, reusable

• Primary Device ID: 00385541062206
• NIH Device Record Key: a4a6e712-0fad-4b88-9c11-f75a25c1647a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AgaMatrix Lancing Device
• Version Model Number: 8300-10622
• 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: false
• 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: false

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
• Phone: 1-866-906-4197
• Email: customerservice@agamatrix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385541062206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230310

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

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: 2023-09-26
• Device Publish Date: 2023-09-18

On-Brand Devices [AgaMatrix Lancing Device]

• 00385541062206: 8300-10622
• 00385540132504: 8300-01325