UltraTrak TM ULTIMATE Blood Glucose Monitoring System

GUDID 00385930011099

VERTEX DIAGNOSTICS LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00385930011099
• NIH Device Record Key: 03d8b36d-78dc-4cbc-8d7f-c3a9ff404d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraTrak TM ULTIMATE Blood Glucose Monitoring System
• Version Model Number: TD-4277
• Company DUNS: 808107788
• Company Name: VERTEX DIAGNOSTICS LLC
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385930011099 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-31
• Device Publish Date: 2020-01-23

Devices Manufactured by VERTEX DIAGNOSTICS LLC

• 00385930000000 - UltraTRAK TM Complete Blood Glucose Monitoring System: 2020-01-31
• 00385930000017 - UltraTRAK Complete 50 Test Strips: 2020-01-31
• 00385930011013 - UltraTRAK TM 50 Test Strips: 2020-01-31
• 00385930011020 - Ultra TRAK PRO Blood Glucose Monitoring System: 2020-01-31
• 00385930011082 - UltraTRAK PRO Blood Glucose Monitoring System: 2020-01-31
• 00385930011099 - UltraTrak TM ULTIMATE Blood Glucose Monitoring System: 2020-01-31
• 00385930011099 - UltraTrak TM ULTIMATE Blood Glucose Monitoring System: 2020-01-31
• 00385930011112 - Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips): 2020-01-31