FDA.reportPublic FDA data

HUDSON RCI

Primary DI
10197344043088
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD99035KIT
Catalog number
HUD99035KIT
Device description
DRI-TECH ADULT CIRCUIT
Published
2024-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234032000Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension LineMedline Industries, LP2024-06-04BZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344043085PackageGS110In Commercial Distribution
10197344043088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734404308520197344043085
1019734404308810197344043088

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Kit
true
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
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10197344176434HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176441HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176458HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344176465HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-04-02
10197344011629HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2026-01-21
10889483617007AirLife™AIRLIFEBZE2025-02-27
09420012448422Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012453204Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
09420012459213Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2024-12-23
10197344043040HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043057HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
10197344043095HUDSON RCIMEDLINE INDUSTRIES, INC.BZE2024-11-22
00848530104153Passive Heated Breathing Circuit KitSunset Healthcare Solutions, Inc.BZE2024-05-30
00848530070670Heated CPAP Tube for DreamStation Series and PR System OneSunset Healthcare Solutions, Inc.BZE2024-03-05
00848530102753Sunset Heated CPAP TubeSunset Healthcare Solutions, Inc.BZE2024-02-20
04048675389583VentStar humidifier chamber (N)Drägerwerk AG & Co. KGaABZE2023-07-21
04048675411758VentStar Helix heated (N) PlusDrägerwerk AG & Co. KGaABZE2023-07-21
04048675414520Double connector 11ID/15OD 20xDrägerwerk AG & Co. KGaABZE2023-07-21
04048675742739VentStar Helix dual heated N Exten. KitDrägerwerk AG & Co. KGaABZE2023-07-21
09420012431080Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012431165Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012432162Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
09420012456601Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZE2022-08-02
05404013004560HybernitePlastiflex Group NVBZE2022-07-03
00848530090609Heated CPAP TubeSunset Healthcare Solutions, Inc.BZE2021-10-14