AirStrip OB Legacy iOS

Basic Information

• Brand Name: AirStrip OB Legacy iOS
• Primary DI: B15310010
• Version / Model: 1001
• Company Name: Airstrip Technologies, Inc.
• Labeler DUNS: 079232437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-13
• Public Version: 4
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: ffcc2eec-f9e7-42e4-b919-0fe8b788f68a

Device Description

OB Legacy System iOS Software System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66386	Bedside monitor remote-viewing software, physiological parameter	An application software program intended to be installed on a smart device (e.g., 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. It is designed for viewing data only as a telemedicine application intended to support, and not replace, standard patient monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B15310010	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]