NuVent™

GUDID 00643169770997

INFLATOR KIT 18INFKIT BALLOON

MEDTRONIC XOMED, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00643169770997
• NIH Device Record Key: 7eeaa536-b123-4cac-99b9-18b2998d9376
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVent™
• Version Model Number: 18INFKIT
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169770997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152121

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-10-13

On-Brand Devices [NuVent™]

• 00643169770997: INFLATOR KIT 18INFKIT BALLOON
• 00643169434837: INFLATOR KIT 18INFKIT BALLOON