NuVent ™

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name: NuVent ™ FDA UDI
Generic Name: Nasal/paranasal balloon catheter FDA UDI
Device Name: BALLOON SEEKER 1830717FRT EM FRNT 7X17MM FDA UDI
Model / Reference: 1830717FRT FDA UDI
Description: BALLOON SEEKER 1830717FRT EM FRNT 7X17MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169420472 FDA UDI
510(k) Number: K132297 FDA UDI
FDA Product Code: LRC FDA UDI
GMDN Term: Nasal/paranasal balloon catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 7.0 Millimeter FDA UDI
Length — 17.0 Millimeter FDA UDI

Category: Nasal/paranasal balloon catheter

NuVent ™ by Medtronic Xomed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K132297 also covers:

NuVent™ — MEDTRONIC XOMED, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Medtronic Xomed, Inc.

Sources (1)

FDA UDI 7ad58e00-7868-4015-b6f6-45c8ca122010 36 fields · synced May 30, 2026