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
10801902224931LMA AIRWAY MANAGEMENT105320-000010105320-0000102026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106430Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2026-08-15
04719874951467Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
00848530107284Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2025-08-19
14026704927453GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
14026704929723GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
00848530062316Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096922Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096946Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096953Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530103637Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096908Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530083274Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
00848530083298Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752105928AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141964AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141988AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752139794AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139817AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139824AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139831AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139992AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22