NuVent

GUDID 00763000416034

BALLOON 1830616EST EUSTACHIAN 6X16MM

MEDTRONIC XOMED, INC.

Eustachian catheter, single-use

• Primary Device ID: 00763000416034
• NIH Device Record Key: f73f2878-c75f-4787-9676-4450fe75cb04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVent
• Version Model Number: 1830616EST
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000416034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210841

FDA Product Code

• PNZ: Eustachian tube balloon dilation device

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: 2021-10-12
• Device Publish Date: 2021-10-04

Devices Manufactured by MEDTRONIC XOMED, INC.

• 00763000578022 - N/A: 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL
• 00763000578039 - N/A: 2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL
• 00763000578046 - N/A: 2024-09-24 SPLINT 1528120 25PK EXTERNAL NASAL MED
• 00763000578053 - N/A: 2024-09-24 SPLINT 1528121 5PK EXTERNAL NASAL MEDIUM
• 00763000578060 - N/A: 2024-09-24 SPLINT 1528137 25PK EXTERNAL NASAL LARGE
• 00763000578077 - N/A: 2024-09-24 SPLINT 1528138 5PK EXTERNAL NASAL LARGE
• 00763000578084 - Thermasplint: 2024-09-24 SPLINT 1529000 10PK THERMASPLINT SMALL
• 00763000578091 - Thermasplint: 2024-09-24 SPLINT 1529010 10PK THERMASPLINT MEDIUM