FDA.reportPublic FDA data

Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level

Primary DI
06955623020147
Brand
Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level
Company
SYSMED (CHINA) CO.,LTD
Model
Aurora Bi-Level S
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
K192177000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192177000SysMed S/TSysmed (China) Co., Ltd.2020-11-25BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06955623020147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955623020147069556230201476955623020147

GMDN Terms#

Term, Definition table
TermDefinition
Intensive-care patient transport system, ventilatory support, adultA mobile (on wheels) assembly of devices intended to be used to transport an adult patient (e.g., between healthcare facilities) with the in-transit provision of high-level critical care including ventilatory support but not extracorporeal life support. It primarily includes ventilatory equipment (e.g., ventilator, nitric oxide delivery unit) and infusion equipment [e.g., syringe driver(s), infusion pump] with appropriate patient monitors, mounted upon a patient trolley/stretcher; emergency airway clearing/resuscitation equipment may also be included.

Regulatory Flags#

DUNS number
548237698
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955623020024Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 30 S/T2026-05-06
06955623020154Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelAurora Bi-Level S/T2026-05-06
06955623020161Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelZiZ CPAP2026-05-06
06955623020185Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 20 S2026-05-06
06955623020192Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 20 S/T2026-05-06
06955623020215Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 25 S2026-05-06
06955623020222Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelResware BI 25 S/T2026-05-06
06955623000033Oxygen ConcentratorMQ502020-12-09
06955623000019Oxygen ConcentratorM502020-11-25

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Primary DI, Brand, Company table
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