FDA.reportPublic FDA data

GIBECK

Primary DI
14026704929457
Brand
GIBECK
Company
TELEFLEX INCORPORATED
Model
IPN929891
Catalog number
10011
Published
2026-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704929454PackageGS130In Commercial Distribution
34026704929451PackageGS120In Commercial Distribution
14026704929457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670492945424026704929454
3402670492945134026704929451
1402670492945714026704929457

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A 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."

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
10889483571576AirLife™AIRLIFEBYD2025-02-21
10889483571583AirLife™AIRLIFEBYD2025-02-21
10889483571590AirLife™AIRLIFEBYD2025-02-21
10889483571637AirLife™AIRLIFEBYD2025-02-21
10889483571644AirLife™AIRLIFEBYD2025-02-21
10889483334577AirLife™AIRLIFEBYD2025-02-20
10889483571545AirLife™AIRLIFEBYD2025-02-20
10889483571569AirLife™AIRLIFEBYD2025-02-20
10889483571613AirLife™AIRLIFEBYD2025-02-20
10889483571620AirLife™AIRLIFEBYD2025-02-20
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
10884521829190DARCovidien LPBYD2023-09-16
10884521829206DARCovidien LPBYD2023-09-16
10884521829213DARCovidien LPBYD2023-09-16
10884521829220DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
10888277702202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BYD2023-01-26
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05