FDA.reportPublic FDA data

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

Primary DI
06955623020222
Brand
Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level
Company
SYSMED (CHINA) CO.,LTD
Model
Resware BI 25 S/T
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
06955623020222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06955623020222069556230202226955623020222

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
06955623020147Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-LevelAurora Bi-Level S2026-05-06
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
06955623000033Oxygen ConcentratorMQ502020-12-09
06955623000019Oxygen ConcentratorM502020-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088881097MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881103MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-24
00850088881035IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04