MicroBlue®

GUDID 20763000040264

VENT TUBE 16191 5PK BLUE PEDIATRIC TITAN

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20763000040264
• NIH Device Record Key: 422661e3-1069-4200-a786-78567ad9e4d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroBlue®
• Version Model Number: 16191
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter
• Lumen/Inner Diameter: 0.76 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000040260 [Primary]
GS1	20763000040264 [Package]; Contains: 00763000040260; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151067

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [MicroBlue®]

• 20763000040264: VENT TUBE 16191 5PK BLUE PEDIATRIC TITAN
• 20763000040011: VENT TUBE 14642 10PK MICROBLUE PAIR 1.27