FDA.reportPublic FDA data

Pedi-Neb Nasal Nebulizer

Primary DI
00709078001598
Brand
Pedi-Neb Nasal Nebulizer
Company
WESTMED, INC.
Model
0383
Device description
VixOne Nebullzer and attached pacifier
Published
2016-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2
CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)Anesthesiology1

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
10709078001595PackageGS112In Commercial Distribution
00709078001598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800159510709078001595
00709078001598007090780015987090780015980709078001598

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, single-useA collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078008818Adaptors/Conectors208438822021-01-29
05707480103195Hyperinflation (AMBU)900 000 6032015-10-24
00709078003028Composite Kit07932017-04-26
00709078003868Humidifier Adaptor04852017-05-26
00709078003899Composite Kit07942017-05-26
00709078005954OxyGo Bubble Humidifier1425-10142018-09-25
00709078007606Bubble Humidifier04802021-02-24
00709078014093Bubble Humidifier10022832022-03-31
00709078014277Bubble Humidifier010-1048582022-03-31
00709078014284Bubble Humidifier10022482022-03-31
00709078003011Composite Kit07922017-04-26
00709078003158Bubble Humidifier07952017-04-26
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704933720TELEFLEXTELEFLEX INCORPORATEDCCQ2026-08-01
14026704714480LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-29
14026704714497LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-29
14026704714503LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-27
04719874955663Create BiotechCREATE BIOTECH CO., LTD.CCQ2026-07-21
04719874955700Create BiotechCREATE BIOTECH CO., LTD.CCQ2026-07-21
14026704714510LMA ATOMIZATIONTELEFLEX INCORPORATEDCCQ2026-07-21
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
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30