AccessGUDID - DEVICE: AirStrip ONE Client iOS (B153301010)

GUDID

Device Identifier (DI) Information

Brand Name: AirStrip ONE Client iOS
Version or Model: 30101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Airstrip Technologies, Inc.

Primary DI Number: B153301010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079232437 *Terms of Use
Previous DI: B15320010

Device Description: AirStrip Cardiology, Patient Monitoring and OB - Client iOS

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66386	Bedside monitor remote-viewing software, physiological parameter	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGM	System, Monitoring, Perinatal
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ad44bf3-0655-4d73-bcd3-4f7c67f4da3e
Public Version Date: June 15, 2026
Public Version Number: 2
DI Record Publish Date: March 18, 2026