FDA.reportPublic FDA data

Transcend

Primary DI
M9505031120
Brand
Transcend
Company
SOMNETICS INTERNATIONAL, INC.
Model
365 miniCPAP TranSync Bluetooth Module
Catalog number
503112
Published
2020-12-02
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180388000Transcend 365 miniCPAP SystemSomnetics International, Inc.2018-11-30BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9505031120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home CPAP unitA portable, mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous respiration, primarily to treat adult patients affected by obstructive sleep apnoea (OSA); it may also be intended to treat snoring. It is a small desktop unit with controls, and may include a built-in humidifier; the airway pressure may be automatically adjusted to help provide optimal CPAP through use of a sensor (auto CPAP). The device is intended for use in the home but may also be used in healthcare facilities.

Contacts#

Phone, Email table
PhoneEmail
877.621.9626info@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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Primary DI, Brand, Company table
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00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
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