FDA.reportPublic FDA data

HUDSON RCI

Primary DI
34026704659365
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN913730
Catalog number
2415
Device description
COMFORT FLO
Published
2023-06-16
Public version status
Update
Distribution status
Not 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
44026704659362PackageGS120Not in Commercial Distribution
14026704659361PreviousGS10
34026704659365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4402670465936244026704659362
1402670465936114026704659361
3402670465936534026704659365

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

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
10197344010493HUDSON 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