FDA.reportPublic FDA data

HUDSON RCI

Primary DI
20197344037190
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD6110T
Catalog number
HUD6110T
Device description
NEB, TURBOMIST, PED MSK, LADT, 7' TUB UC
Published
2024-03-05
Public version status
Update
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
K230602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230602000Hudson RCI® TurboMist™ Nebulizer SystemMedline Industries, LP2023-10-31CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344037193PackageGS150In Commercial Distribution
20197344037190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734403719310197344037193
2019734403719020197344037190

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344205281CURADCUR47451RBCUR47451RB2026-10-29
00884389108362CURADCUR4025RCUR4025R2026-10-29
00884389108393CURADCUR4135RCUR4135R2026-10-29
00888277187088CURADCUR4125RCUR4125R2026-10-29
10197344148608MEDLINERTDCIVDHGRTDCIVDHG2026-10-29
10197344148615MEDLINERTDCIVDHNRTDCIVDHN2026-10-29
10197344148622MEDLINERTDCIVDHPRTDCIVDHP2026-10-29
10197344148639MEDLINERTDCIVDHRRTDCIVDHR2026-10-29
10197344148646MEDLINERTDCIVDHYRTDCIVDHY2026-10-29
10197344148653MEDLINERTDCIVDHZRTDCIVDHZ2026-10-29
10197344219278MEDLINEDYNDSCL3000RDYNDSCL3000R2026-10-29
10197344223862MEDLINEDYSNR24OVCOLDDYSNR24OVCOLD2026-10-29
10653160395690MEDLINEDYNDC3636DYNDC36362026-10-29
10653160395768MEDLINECVI5130BCVI5130B2026-10-29
10653160395874MEDLINEEBSI1161BEBSI1161B2026-10-29
10653160395935MEDLINEDYNDH2410DYNDH24102026-10-29
10653160395966MEDLINEEBSI1729BEBSI1729B2026-10-29
10653160396017MEDLINEEBSI1427BEBSI1427B2026-10-29
10653160396024MEDLINEDYNDC3648DYNDC36482026-10-29
10653160396031MEDLINEEBSI1840AEBSI1840A2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109929Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-10-19
00848530109936Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-10-19
00812574027310CuraplexTRI-ANIM HEALTH SERVICES, INC.CAF2026-10-16
10197344042388HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
10197344042395HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
00848530109912Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-09-30
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
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30