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AirStrip ONE

FDA UDI

Class II (US FDA UDI)

by AirStrip Technologies, Inc.

Identity

Trade Name
AirStrip ONE FDA UDI
Generic Name
Bedside monitor remote-viewing software, physiological parameter FDA UDI
Device Name
AirStrip Cardiology, Patient Monitoring, OB - Server Platform FDA UDI
Model / Reference
2000 FDA UDI
Description
AirStrip Cardiology, Patient Monitoring, OB - Server Platform FDA UDI

Identifiers

Primary DI / UDI-DI
B15320000 FDA UDI
FDA Product Code
HGM FDA UDI
MWI FDA UDI
MSX FDA UDI
GMDN Term
Bedside monitor remote-viewing software, physiological parameter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2740 FDA UDI
870.2300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bedside monitor remote-viewing software, physiological parameter

AirStrip ONE by AirStrip Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bedside monitor remote-viewing software, physiological parameter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AirStrip Technologies, Inc.

Sources (1)

  • FDA UDI cb1beb2e-b593-4c26-957f-c5112e4d9aeb 33 fields · synced Jun 9, 2026