UltraTRAK TM 50 Test Strips

GUDID 00385930011013

VERTEX DIAGNOSTICS LLC

Glucose IVD, kit, electrometry

• Primary Device ID: 00385930011013
• NIH Device Record Key: deb9d13c-5dd3-4436-9489-5488829afd4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraTRAK TM 50 Test Strips
• Version Model Number: TD-4255&TD-4275
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385930011013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082618

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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
• 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
• 00385930011112 - Ultra TRAK TM ULTIMATE TEST STRIP (50 Test Strips): 2020-01-31