FDA.reportPublic FDA data

HUDSON RCI

Primary DI
10197344011629
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD05014
Catalog number
HUD05014
Device description
AQUATHERM III HEATER,ADJUST,LVN
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
CAFNebulizer (direct patient interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223100000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223100000Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)Medline Industries, Inc.2023-06-27CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10197344011629PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019734401162910197344011629

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent vaporizer, benchtopAn assembly of devices intended to be used in the home and clinical settings to vaporize (through heating) medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It includes an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held inhalation compartment (e.g., inflatable balloon with mouthpiece).¿¿It is designed to be placed on a benchtop/flat surface during use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry; Keep away from sunlight.
Storage Environment Humidity0 Percent (%) Relative Humidity94 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

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
10889483642795AirLifeAIRLIFEBZE2026-10-16
00848530108885Breathing CircuitSunset Healthcare Solutions, Inc.BZE2026-10-12
00848530108892Breathing CircuitSunset Healthcare Solutions, Inc.BZE2026-10-12
10197344042388HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
10197344042395HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2026-10-08
00819989012399S10 Heated CPAP TubeEXCELERON MEDICAL, INC.BZE2026-10-05
00848530109912Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-09-30
10197344039418HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043064HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043071HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043101HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
10197344043118HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-09-04
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
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
10889483617007AirLife™AIRLIFEBZE2025-02-27
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