FDA.reportPublic FDA data

NuVent

Primary DI
00763000416034
Brand
NuVent
Company
MEDTRONIC XOMED, INC.
Model
1830616EST
Device description
BALLOON 1830616EST EUSTACHIAN 6X16MM
Published
2021-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNZEustachian tube balloon dilation device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNZEustachian Tube Balloon Dilation DeviceEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210841000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210841000NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.2021-08-16PNZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000416034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000416034007630004160347630004160340763000416034

GMDN Terms#

Term, Definition table
TermDefinition
Eustachian catheter, single-useA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
835465063
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150064069ApexCut187BL40002026-04-25
00199150064076ApexCut187BL4000L2026-04-25
00199150064083ApexCut187BL40122026-04-25
00199150064090ApexCut187BL40402026-04-25
00199150064106ApexCut187BL40602026-04-25
00763000945640ApexCut187BL29002026-04-25
00763000945657ApexCut187BL35002026-04-25
00763000945718ApexCut187BL35122026-04-25
00763000945732ApexCut187BL35402026-04-25
00763000945756ApexCut187BL29602026-04-24
00763000945763ApexCut187BL35602026-04-25
00763000945787ApexCut187BL29752026-04-25
00763000945794ApexCut187BL35902026-04-25
00763000945800ApexCut187BL351202026-04-25
20643169782666NIM Trivantage®82297392016-11-12
20763000041544NIM TriVantage®82297392020-02-29
00763000033972NIM TriVantage®82297092020-02-15
20681490055158Merocel®22185352017-10-16
00643169782617NIM Trivantage®82297092016-11-12
00613994176547Reuter10103012015-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260759931680VenSure 4D Balloon Dilation SystemFiagon GmbHPNZ2025-09-18
04250676745088TubaVent® balloon dilatation systemSpiggle & Theis Medizintechnik GmbHPNZ2025-02-27
04250676743473Inflation deviceSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743503TubaVent® shortSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743510TubaVent® short wideSpiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04250676743527TubaInsert® - Type 45°Spiggle & Theis Medizintechnik GmbHPNZ2023-09-07
04260759931246VenSure Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931260VenSure Nav Balloon Dilation SystemFiagon GmbHPNZ2022-11-10
04260759931253VenSure Light Balloon Dilation SystemFiagon GmbHPNZ2022-10-14
00850002250428Audion STRYKER CORPORATIONPNZ2022-06-03
10705031465565ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465572ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
10705031465596ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465579ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465586ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465609ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
20705031465616ACCLARENT PIVOTACCLARENT, INC.PNZ2020-10-01
00857326005000XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005017XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005024XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005031XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005048XprESS LoProfileSTRYKER CORPORATIONPNZ2017-11-27
00857326005055XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005062XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005079XprESS ProSTRYKER CORPORATIONPNZ2017-11-27
00857326005116XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005123XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005130XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
00857326005147XprESS UltraSTRYKER CORPORATIONPNZ2017-11-27
10705031230880ACCLARENT AERAACCLARENT, INC.PNZ2016-11-17