FDA.reportPublic FDA data

HUDSON RCI

Primary DI
10197344010493
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD88013KIT
Catalog number
HUD88013KIT
Device description
CIRCUIT,ISO-GARD,INFANT,HTD,COLUMN,DRN
Published
2025-09-22
Public version status
New
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
OGGHumidifier nebulizer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGGHumidifier Nebulizer KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344010490PackageGS120In Commercial Distribution
10197344010493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734401049020197344010490
1019734401049310197344010493

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 dry. Keep away from sunlight.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344010486HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-10-31
10197344010370HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-10-17
10197344010394HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010462HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010479HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010912HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010943HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
10197344010967HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
20197344010391HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-09-22
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
10197344010752HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10197344010905HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10197344010950HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010759HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010902HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
20197344010957HUDSON RCIMEDLINE INDUSTRIES, INC.OGG2025-08-18
10889483598542AirLife™AIRLIFEOGG2025-03-07
10889483598573AirLife™AIRLIFEOGG2025-03-07
10889483598580AirLife™AIRLIFEOGG2025-03-07
30889483598546AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598577AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
30889483598584AirLife™Sunmed Group Holdings, LLCOGG2025-03-07
10889483598559AirLife™AIRLIFEOGG2025-02-27
30889483598553AirLife™Sunmed Group Holdings, LLCOGG2025-02-27
34026704659365HUDSON RCITELEFLEX INCORPORATEDOGG2023-06-16