FDA.reportPublic FDA data

AirStrip ONE

Primary DI
B15320010
Brand
AirStrip ONE
Company
Airstrip Technologies, Inc.
Model
2001
Device description
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal
MWIMonitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B15320010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bedside physiologic monitoring softwareAn application software program intended to collect real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from a bedside monitor(s) to facilitate patient data management and communication, and may notify clinicians of events, patients at risk, or manage workflows; it is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079232437
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B153301030AirStrip ONE Client Web301032026-03-18
B153300010AirStrip ONE Platform300012026-03-18
B153301010AirStrip ONE Client iOS301012026-03-18
B153301020AirStrip ONE Client Android301022026-03-18
B153500010AirStrip Alarm Management500012026-03-18
B15310000AirStrip OB Legacy Server10002018-09-13
B15310010AirStrip OB Legacy iOS 10012018-09-13
B15320000AirStrip ONE 20002017-10-09
B15320020AirStrip ONE 20022017-10-09
B15320030AirStrip ONE Web Client20032018-09-13
B15320100AirStrip ONE 20102017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.MWI2026-05-27
08719689142124QMAPP Fysicon B.V.MWI2026-05-19
08719689142131QMAPP Fysicon B.V.MWI2026-05-19
08719689142162QMAPP Fysicon B.V.MWI2026-05-19
08719689142179QMAPP Fysicon B.V.MWI2026-05-19
10197344213245MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213252MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-05-08
10197344213238MEDLINEMEDLINE INDUSTRIES, INC.MWI2026-04-23
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MWI2026-03-18