FDA.reportPublic FDA data

Transcend

Primary DI
M9505030800
Brand
Transcend
Company
SOMNETICS INTERNATIONAL, INC.
Model
Water Reservoir
Catalog number
503080
Published
2019-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131388000TRANSCEND HEATED HUMIDIFIERSomnetics International, Inc.2013-09-26BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9505030800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Contacts#

Phone, Email table
PhoneEmail
8776219626info@somnetics.com

Regulatory Flags#

DUNS number
047069263
Device count
1
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

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