FDA.reportPublic FDA data

Transcend

Primary DI
M9505030980
Brand
Transcend
Company
SOMNETICS INTERNATIONAL, INC.
Model
P10 Battery
Catalog number
503098
Published
2019-01-03
Public version status
Update
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
M9505030980PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet. It is typically used during a transport situation (e.g., a neonatal incubator) or when it is designed to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius45 Degrees Celsius
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@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425034Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012425041Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448446Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448514Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448521Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012448736Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012456434Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464644Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
09420012464682Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
04719893347272WellellWellell Inc.BZD2026-03-17
09420012461629F&P ViteraFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-01-27
09420012472212NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472229NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472236NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472243NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472366NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472373NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472380NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
09420012472397NovaFISHER & PAYKEL HEALTHCARE LIMITEDBZD2025-09-15
08056814676223DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676247DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676254DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676261DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676377DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676384DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676391DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676407DIMARHMC PREMEDICAL SPABZD2025-03-20
08056814676230DIMARHMC PREMEDICAL SPABZD2025-03-20