WVSM Wireless Vital Signs Monitor

Basic Information

• Brand Name: WVSM Wireless Vital Signs Monitor
• Primary DI: B3945000025010
• Version / Model: WVSM SurgeCase/10
• Catalog Number: 500-0025-01
• Company Name: ATHENA GTX, INC.
• Labeler DUNS: 048031913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-06
• Public Version: 5
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: b705e10f-0759-4bb2-bc73-916bc8b7bebd

Device Description

Carry case/Charger for 10 WVSMs - Black

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
DQA	Oximeter	Cardiovascular	870.2700	2
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. This is a reusable device.	No	Active
12500	Medical bag	A portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3945000025010	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101674	000
K130957	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius