FDA.reportPublic FDA data

HME Flex

Primary DI
10850014574793
Brand
HME Flex
Company
PEPPER MEDICAL INC.
Model
HME-712-Flex
Catalog number
HME-712-Flex
Device description
HME with Flex Tube
Published
2023-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
10850014574816PackageGS125In Commercial Distribution
10850014574793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085001457481610850014574816
1085001457479310850014574793

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(800)647-0172gschuster@peppermedical.com

Regulatory Flags#

DUNS number
622637098
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014574208Foley Loc6506502020-04-17
00850014574185Foley Tie6066062020-04-17
00850014574192Tube Tie544554452020-04-17
10850014574014Pepper Medical Closed SuctionCS24-DS-14CS24-DS-142025-09-11
10850014574038Pepper Medical Closed SuctionCS24-T-14CS24-T-142025-09-11
10850014574052Pepper Medical Closed SuctionCS24-10-ETTCS24-10-ETT2025-09-11
00850014574659Pepper MedicalHME-712-Mini2025-11-07
00850014574406Trach Tie5025022020-04-17
00850014574413Trach Tie502P502P2020-04-17
00850014574154Trach Tie501W501W2020-04-17
00850014574215Trach Tie100110012020-04-17
10850014574878Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574892Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574915Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014574922Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15
10850014574830Pepper Medical Closed SuctionCS24-12-ETTCS24-12-ETT2025-09-15
10850014574861Pepper Medical Closed SuctionCS24-6CS24-62025-09-15
10850014574885Pepper Medical Closed SuctionCS24-8-ETTCS24-8-ETT2025-09-15
10850014574908Pepper Medical Closed SuctionCS24-T-12CS24-T-122025-09-15
10850014575066Pepper Medical Closed SuctionCS24-T-16CS24-T-162025-09-15

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
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10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
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10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
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10190752139824AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
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