FDA.reportPublic FDA data

VixOne™

Primary DI
10889483231234
Brand
VixOne™
Company
SUNMED, LLC
Model
0233
Catalog number
0233
Device description
VixOne™ Small Volume Nebulizer
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800562000DISPOSABLE HAND HELD NEBULIZERIntec Medical, Inc.1980-03-25CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483231231PackageGS150Not in Commercial Distribution
00709078006197PreviousGS10
10889483231234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088948323123120889483231231
00709078006197007090780061977090780061970709078006197
1088948323123410889483231234

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, reusableA collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21
10889483564479BALLARD™2260-52260-52025-11-21
10889483564486BALLARD™22606-522606-52025-11-21
10889483564554BALLARD™22703-522703-52025-11-21
10889483564578BALLARD™227036-5227036-52025-11-21
10889483564691BALLARD™227135-5227135-52025-11-21
10889483564875BALLARD™227161863-5227161863-52025-11-21
10889483564882BALLARD™22716186-522716186-52025-11-21
10889483564899BALLARD™22716-522716-52025-11-21
10889483623473BALLARD™22701356-522701356-52025-11-21
10889483623480BALLARD™2270156-52270156-52025-11-21
10889483623558BALLARD™22715-522715-52025-11-21
10889483623565BALLARD™227156-5227156-52026-01-16
10889483563670BALLARD™196-5196-52025-11-20
10889483563700BALLARD™197-5197-52025-11-20
10889483563731BALLARD™198-5198-52025-11-20
10889483563762BALLARD™200-5200-52025-11-20
10889483563861BALLARD™205-5205-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
00840117308695Resp-O2 Elite Compressor Nebulizer, Adult/PediatricDynarex CorporationCAF2022-05-11
00840117308718Resp-O2 Compact Compressor NebulizerDynarex CorporationCAF2022-05-11
00840117308732My Resp-O2 Bear Compressor NebulizerDynarex CorporationCAF2022-05-11
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699205MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699229MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699236MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.CAF2021-10-01
00888277692100MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18