FDA.report

HUDSON RCI

Primary DI
24026704597356
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN043830
Catalog number
19915-72
Device description
Gibeck Humid Flo Passive Humidification Kit
Published
2016-09-16
Public version status
Update
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
24026704597356PackageGS110Not in Commercial Distribution
04026704597352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
2402670459735624026704597356
04026704597352040267045973524026704597352

GMDN Terms

TermDefinition
Heat/moisture exchanger, single-useA one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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
false
Expiration date on label
false
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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