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NuVent™

FDA UDI

Class I (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
NuVent™ FDA UDI
Generic Name
Catheter/overtube balloon inflator, single-use FDA UDI
Device Name
INFLATOR KIT 18INFKIT BALLOON FDA UDI
Model / Reference
18INFKIT FDA UDI
Description
INFLATOR KIT 18INFKIT BALLOON FDA UDI

Identifiers

Primary DI / UDI-DI
00643169434837 FDA UDI
510(k) Number
K132297 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Catheter/overtube balloon inflator, single-use 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Catheter/overtube balloon inflator, single-use

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

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

Cleared under the same submission

K132297 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 36fc7875-419e-4fd3-9b92-c7dd6f41db7e 35 fields · synced Jun 8, 2026