FDA.reportPublic FDA data

GIBECK

Primary DI
14026704929495
Brand
GIBECK
Company
TELEFLEX INCORPORATED
Model
IPN929895
Catalog number
11012
Device description
HUMID VENT FILTER PEDI
Published
2025-07-31
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
BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952084000HUMID-VENT FILTER PEDIGibeck, Inc.1995-06-12BYD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704929492PackageGS120In Commercial Distribution
34026704929499PackageGS110In Commercial Distribution
14026704929495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670492949224026704929492
3402670492949934026704929499
1402670492949514026704929495

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial medical gas filterA device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. 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
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
10801902226379ARROWIPNB00682ASK-42703-CWH12026-07-14
10801902226386ARROWIPNB00683ASK-45703-CWH12026-07-14
10801902202243ARROWIPN922628ASK-19608-US12026-07-13
14026704927910PILLINGIPN0079065068002026-07-08
10801902226171ARROWPR-45552-BASPR-45552-BAS2026-07-06
10841156112035LANGSTONIPN93901955402026-06-26
10801902218732ARROWIPN928981CS-15853-E2026-06-24
10801902221725ARROWIPN930533EC-055002026-06-24
14026704664983HUDSON RCIIPN039676158002026-06-24
14026704664990HUDSON RCIIPN039677158022026-06-24
14026704665003HUDSON RCIIPN039678158042026-06-24
14026704665027HUDSON RCIIPN039680158082026-06-24
14026704665034HUDSON RCIIPN039681158102026-06-24
14026704665164HUDSON RCIIPN03969412712026-06-24
14026704665171HUDSON RCIIPN03969512722026-06-24
14026704665195HUDSON RCIIPN03969712742026-06-24
14026704665201HUDSON RCIIPN03969812752026-06-24
14026704924254PLEUR-EVACIPN929357PE104-082026-06-24
15060112315029LMA AIRWAY MANAGEMENTIPN0487781280302026-06-24
15060112315036LMA AIRWAY MANAGEMENTIPN0487801280402026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
10859760005056Passy Muir PASSY-MUIR, INC.BYD2025-02-03
10810050855621ThermoFlo®TYPENEX MEDICAL LLCBYD2024-11-14
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
10850014574793HME FlexPEPPER MEDICAL INC.BYD2023-10-25
10884521082502DARCovidien LPBYD2023-09-16
10884521829060DARCovidien LPBYD2023-09-16
10884521829152DARCovidien LPBYD2023-09-16
10884521829183DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
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10190752139831AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139992AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10193489139983MedlineMEDLINE INDUSTRIES, INC.BYD2022-08-04
10193489331172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BYD2022-08-04