FDA.report

HUDSON RCI

Primary DI
20197344010391
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD88034KIT
Catalog number
HUD88034KIT
Device description
ISO-GARD CIRCUIT,ADLT,DL,HTD,DRAIN
Published
2025-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OGGHumidifier nebulizer kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344010391PackageGS110In Commercial Distribution
10197344010394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734401039120197344010391
1019734401039410197344010394

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10080196163885MEDLINENONTH100BNONTH100B2026-03-24
10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20197344010469HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010476HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010490HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010919HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010940HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010964HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010759HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010902HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010957HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
30889483598546AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598577AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598584AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598553AirLife™Sunmed Group Holdings, LLCOGG2025-02-27
44026704659362HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16
44026704659379HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16
40193489423830Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGG2022-01-02
50190752158489AirLife™VYAIRE MEDICAL, INC.OGG2021-04-19
50190752152098AirLife™VYAIRE MEDICAL, INC.OGG2021-03-26
50190752158458AirLife™VYAIRE MEDICAL, INC.OGG2021-03-26
50190752160192AirLife™VYAIRE MEDICAL, INC.OGG2021-03-26
50190752156669AirLife™VYAIRE MEDICAL, INC.OGG2021-03-19
24026704717761HUDSON RCITELEFLEX INCORPORATEDOGG2020-08-18
16971331400320YirdocQingdao Future Medical Technology Co., Ltd.OGG2020-06-22
10709078007788Composite Respiratory KitWESTMED, INC.OGG2019-10-18
34026704627869HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
34026704627951HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
34026704627975HUDSON RCITELEFLEX INCORPORATEDOGG2019-09-02
14026704627988HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07
14026704628466HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07
14026704628473HUDSON RCITELEFLEX INCORPORATEDOGG2019-08-07