FDA.reportPublic FDA data

AirStrip ONE Client iOS

Primary DI
B153301010
Brand
AirStrip ONE Client iOS
Company
Airstrip Technologies, Inc.
Model
30101
Device description
AirStrip Cardiology, Patient Monitoring and OB - Client iOS
Published
2026-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
B15320010PreviousHIBCC0
B153301010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bedside monitor remote-viewing software, physiological parameterAn application software program intended to be installed on a non-medical off-the-shelf device (e.g., computer/smartphone/tablet) to allow a healthcare professional to view real-time and historical patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] from bedside monitors via data transmission through a centralized patient monitor or data network server. It is designed for viewing data only as a remote or telemedicine application (e.g., in a hospital patient monitoring room, or clinician’s office) intended to support, and not replace, standard patient monitoring.

Contacts#

Phone, Email table
PhoneEmail
1-877-258-5869cases@airstrip.com

Regulatory Flags#

DUNS number
079232437
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B153300010AirStrip ONE Platform300012026-03-18
B153301020AirStrip ONE Client Android301022026-03-18
B153301030AirStrip ONE Client Web301032026-03-18
B153500010AirStrip Alarm Management500012026-03-18
B15310000AirStrip OB Legacy Server10002018-09-13
B15310010AirStrip OB Legacy iOS 10012018-09-13
B15320000AirStrip ONE 20002017-10-09
B15320010AirStrip ONE 20012017-10-09
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
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyMWI2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyMWI2026-07-21
03615041990578Capsule SurveillancePhilips North America LLCMWI2026-07-14
08684906452600Arc SystemM2AN DIGITAL HEALTH INC.MWI2026-06-29
04255629200966NIBP Pressure cuff 9 - 15 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200973NIBP Pressure cuff 14 - 21,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200980NIBP Pressure cuff 20,5 - 28,5 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201017Gas Sample Line SetMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.MWI2026-06-03
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