Activent®

GUDID 20681490030995

VENT TUBE 1038050 5PK STR SHANK 1.14

MEDTRONIC XOMED, INC.

Tympanostomy tube

• Primary Device ID: 20681490030995
• NIH Device Record Key: c2e67cda-a832-472a-a240-e7f480b05d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activent®
• Version Model Number: 1038050
• 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
• 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

• Length: 7 Millimeter
• Length: 7 Millimeter
• Length: 7 Millimeter
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00681490030991 [Primary]
GS1	20681490030995 [Package]; Contains: 00681490030991; Package: PK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961873

FDA Product Code

• ETD: TUBE, TYMPANOSTOMY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-20

On-Brand Devices [Activent®]

• 20681490030995: VENT TUBE 1038050 5PK STR SHANK 1.14
• 20681490029555: VENT TUBE 1026030 5PK UMBRELLA W/TAB