FDA.reportPublic FDA data

Transcend

Primary DI
M950505015
Brand
Transcend
Company
SOMNETICS INTERNATIONAL, INC.
Model
AirMist Cartridges 8
Catalog number
505015
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
M950505015PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8776219626info@mytranscend.com

Regulatory Flags#

DUNS number
047069263
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9505050340TranscendMicro WhisperSoft Muffler - S5050342024-01-31
M9505050010TranscendMicro PowerAway Battery5050012024-01-31
M9505050170TranscendMicro PureFresh5050172024-01-31
M9505050330TranscendMicro WhisperSoft Muffler - C5050332024-01-31
M9505060010TranscendMicro CPAP5060012023-08-22
M950503119TranscendAirFlex 45031192022-08-03
M950503120TranscendAirFlex 65031202022-08-03
M950503121TranscendWhisperSoft 45031212022-08-03
M950503122TranscendWhisperSoft 65031222022-08-03
M950503123TranscendWhisperSoft 45031232022-08-03
M950503124TranscendWhisperSoft 65031242022-08-03
M950505002TranscendWhisperSoft5050022022-08-03
M950505003TranscendWhisperSoft Micro5050032022-08-03
M950505004TranscendAirFlex Micro 65050042022-08-03
M950505025TranscendWhisperSoft Micro 45050252022-08-03
M950505026TranscendWhisperSoft Micro 65050262022-08-03
M950505027TranscendAirFlex Micro 45050272022-08-03
M950505028TranscendWhisperSoft Micro 45050282022-08-03
M950505029TranscendWhisperSoft Micro 65050292022-08-03
M9505030230TranscendP8 Battery5030232019-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10889483571576AirLife™AIRLIFEBYD2025-02-21
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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