FDA.reportPublic FDA data

AirStrip Alarm Management

Primary DI
B153500010
Brand
AirStrip Alarm Management
Company
Airstrip Technologies, Inc.
Model
50001
Device description
AirStrip ONE Web Client with Alarm Communication Management (ACM) - AirStrip Alarm Management (AAM)
Published
2026-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MSXSystem, Network And Communication, Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211949000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B153500010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physiologic monitoring system alarmAn electronic device intended to be connected to a physiologic monitoring system to provide an audible and/or visual indicator, in the event of out-of-range parameter detection, to notify medical staff that (urgent) assistance is needed by the patient. It is used by medical professionals and caregivers in the healthcare facility.

Contacts#

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

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
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
00884838107816Measurement Rack 6000Philips Medizin Systeme Böblingen GmbHMSX2026-05-19
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-04-17
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.MSX2026-03-18
B153301030AirStrip ONE Client WebAirstrip Technologies, Inc.MSX2026-03-18
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2026-03-09
00843997019019Patient SafetyNet LiteMASIMO CORPORATIONMSX2026-02-23
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.MSX2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyMSX2025-12-10
00884838127456Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00884838127463Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-11-17
00851725007399Central StationNihon Kohden Digital Health Solutions, LLCMSX2025-06-30
00853858006584EmpaticaEMPATICA SRLMSX2025-06-26
00884838127432Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHMSX2025-05-06
G2871002HUMAMedoPad Inc.MSX2025-04-28
00850064210262Sibel Spacelabs Trek TabletSibel Health Inc.MSX2025-04-02
00850064210163Central Hub CMSSibel Health Inc.MSX2025-03-27
00850064210194Central Hub SpeakerSibel Health Inc.MSX2025-03-27
00850064210132ANNE View Patient MonitorSibel Health Inc.MSX2025-03-26
00884838126381eCareManagerPhilips Medical Systems Nederland B.V.MSX2025-03-17
00860011811961MessengerSPOK INC.MSX2025-02-19
04048675673408Gateway Software Server VF9.0.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675762256Gateway Software Server VF9.1.1DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04048675777762Gateway Software Server VF9.1.2DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098007061Infinity Gateway USB DongleDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099264S/W SUB VF9.0 GatewayDRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19
04049098099608Gateway Software Server VF9.0DRAEGER MEDICAL SYSTEMS, INC.MSX2025-02-19