FDA.reportPublic FDA data

Curaplex

Primary DI
00812574025941
Brand
Curaplex
Company
TRI-ANIM HEALTH SERVICES, INC.
Model
301-1013
Catalog number
301-1013
Device description
Curaplex ClearPath HME
Published
2017-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00812574025958PackageGS125In Commercial Distribution
00812574025965PackageGS18In Commercial Distribution
00812574025941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812574025958008125740259588125740259580812574025958
00812574025965008125740259658125740259650812574025965
00812574025941008125740259418125740259410812574025941

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."

Regulatory Flags#

DUNS number
010712461
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812574022032Curaplex301-44F50-1002016-12-14
00818834020343Curaplex301-44F10-120301-44F10-1202017-04-18
00818834020350Curaplex301-12218301-122182017-04-18
00818834028134Curaplex301-12218301-122182019-07-01
00818834028387Curaplex301-12230301-122302020-11-30
00818834028417Curaplex301-0903301-09032020-11-30
00818834028837MiiS Horus Endoscope Display System -Video BoxEVS 7002025-08-12
00812574026481Curaplex301-P3002EA2017-02-06
00818834028608Curaplex301-12218301-122182024-03-10
00818834028615Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028622Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028639Curaplex301-12218301-122182024-03-10
00818834028646Curaplex301-44F10-120301-44F10-1202024-03-10
00818834028684Curaplex301-44F50-100301-44F50-1002024-03-10
00818834028448Curaplex301-PrO2LT301-PrO2LT2024-01-10
00818834028455Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2024-01-10
00818834028462Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2024-01-10
00818834028479Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2024-01-10
00818834028486Curaplex301-PrO2LTEZ301-PrO2LTEZ2024-01-10
00818834028493Curaplex301-PrO2LT-FM301-PrO2LT-FM2024-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848253002224InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002231InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002248InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002279InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002286InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002309InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002316InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002323InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
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
07331791015854TrachPhone (5 pcs)Atos Medical ABBYD2023-06-19
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791002861TrachPhone (50 pcs)Atos Medical ABBYD2022-11-29
07331791009693TrachPhone (30 pcs)Atos Medical ABBYD2022-11-29