FDA.reportPublic FDA data

AirStrip OB Legacy iOS

Primary DI
B15310010
Brand
AirStrip OB Legacy iOS
Company
Airstrip Technologies, Inc.
Model
1001
Device description
OB Legacy System iOS Software System
Published
2018-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B15310010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Total testosterone IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total testosterone in a clinical specimen.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-258-5869support@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
B153500010AirStrip Alarm Management500012026-03-18
B15310000AirStrip OB Legacy Server10002018-09-13
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
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
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05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21