NuVent ™

GUDID 00643169420434

BALLOON SEEKER 1830607MAX EM MAXL 6X7MM

MEDTRONIC XOMED, INC.

Nasal/paranasal balloon catheter

• Primary Device ID: 00643169420434
• NIH Device Record Key: 681fa998-ff25-450b-a3b6-0fb9474aff4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuVent ™
• Version Model Number: 1830607MAX
• 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

Device Dimensions

• Length: 7 Millimeter
• Length: 7 Millimeter
• Length: 7 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter
• Outer Diameter: 6 Millimeter
• Length: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169420434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132297

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: 2019-06-07
• Device Publish Date: 2017-09-08

On-Brand Devices [NuVent ™]

• 00643169770980: BALLOON SEEKER 1830717SPH EM SPHN 7X17MM
• 00643169770973: BALLOON SEEKER 1830717FRT EM FRNT 7X17MM
• 00643169770966: BALLOON SEEKER 1830707MAX EM MAXL 7X7MM
• 00643169770959: BALLOON SEEKER 1830617SPH EM SPHN 6X17MM
• 00643169770942: BALLOON SEEKER 1830617FRT EM FRNT 6X17MM
• 00643169770935: BALLOON SEEKER 1830607MAX EM MAXL 6X7MM
• 00643169770928: BALLOON SEEKER 1830517SPH EM SPHN 5X17MM
• 00643169770911: BALLOON SEEKER 1830517FRT EM FRNT 5X17MM
• 00643169770904: BALLOON SEEKER 1830507MAX EM MAXL 5X7MM
• 00643169705302: BALLOON SEEKR 1830517FRT70 70DG FRT 5X17
• 00643169705296: BALLOON SEEKR 1830617FRT70 70DG FRT 6X17
• 00643169705289: BALLOON SEEKR 1830717FRT70 70DG FRT 7X17
• 00643169420489: BALLOON SEEKER 1830717SPH EM SPHN 7X17MM
• 00643169420472: BALLOON SEEKER 1830717FRT EM FRNT 7X17MM
• 00643169420465: BALLOON SEEKER 1830707MAX EM MAXL 7X7MM
• 00643169420458: BALLOON SEEKER 1830617SPH EM SPHN 6X17MM
• 00643169420441: BALLOON SEEKER 1830617FRT EM FRNT 6X17MM
• 00643169420434: BALLOON SEEKER 1830607MAX EM MAXL 6X7MM
• 00643169420427: BALLOON SEEKER 1830517SPH EM SPHN 5X17MM
• 00643169420410: BALLOON SEEKER 1830517FRT EM FRNT 5X17MM
• 00643169420403: BALLOON SEEKER 1830507MAX EM MAXL 5X7MM