FDA.reportPublic FDA data

Sparky the Dog Pediatric Nebulizer

Primary DI
00372217005032
Brand
Sparky the Dog Pediatric Nebulizer
Company
ARISE MEDICAL LLC
Model
240485
Device description
Sparky the Dog Pediatric Nebulizer
Published
2019-05-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K043238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043238000COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESEmg Technology Co., Ltd.2005-07-06CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00372217005032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00372217005032003722170050323722170050320372217005032

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081149273
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00372217003014ProCare IR Thermometer2403902018-10-01
00372217037019Procare Tens Machine2404982019-06-27
00372217036081Safecare Vinyl Exam Gloves2404952023-02-08
00372217036098Safecare Vinyl Exam Gloves2404962023-02-08
00372217036104Safecare Vinyl Exam Gloves2404972023-02-08
00372217036319Safecare Vinyl Exam Gloves2404932023-02-08
00372217036326Safecare Vinyl Exam Gloves2404942023-02-08
00372217003021Procare Forehead Infrared Thermometer240540PG-IRT16022020-07-13
00372217005094Safari Express Pediatric Nebulizer2405382020-08-22
00372217005100Timmy the Tiger Pediatric Nebulizer2405432020-08-22
00372217000013Pro-Care Nebulizer EasyEasy2018-12-01
00372217005018ProCare Nebulizer Basic2403912018-11-22
00372217005025Procare Compact Compressor Nebulizer2403922018-12-21
00372217004035Procare Basic Upper Arm BP Monitor2404842020-08-22
00372217004042Procare Upper Arm BP Monitor with XL Cuff2405312020-08-22
00372217039037Procare Spacer Chamber2405302020-08-22
00372217006015"Ultra-Care Pen Needles 31G 1/4"" 100 Ct"2403932018-11-29
00372217006022"Ultra-Care Pen Needles 31G 3/16"" 100 Ct"2403942018-11-29
00372217006039"Ultra-Care Pen Needles 31G 5/16"" 100 Ct"2403952018-11-29
00372217006046"Ultra-Care Pen Needles 32G 1/4"" 100 Ct"2403962018-11-29

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
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
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
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30