WVSM Wireless Vital Signs Monitor 500-0001-12

GUDID B3945000001120

Wireless Patient Monitor

ATHENA GTX, INC.

Transportable physiologic monitoring system

• Primary Device ID: B3945000001120
• NIH Device Record Key: d0af3a77-3440-4ba2-938e-3ddd419db872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WVSM Wireless Vital Signs Monitor
• Version Model Number: WVSM 5.0
• Catalog Number: 500-0001-12
• Company DUNS: 048031913
• Company Name: ATHENA GTX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3945000001120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101674

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-12-06

On-Brand Devices [WVSM Wireless Vital Signs Monitor]

• B3945700025050: BP Extension Hose-5 ft
• B3945700025040: BP Extension Hose-4 ft
• B3945700025030: BP Extension Hose-3 ft
• B3945700025020: BP Extension Hose-2 ft
• B3945700025010: BP Extension Hose-1 ft
• B3945700024010: Shoulder Strap-Black
• B3945700004020: ECG Lead Wires - Bonded
• B3945700004010: ECG Lead Wires - Unbonded
• B3945500039010: USB Data Cable
• B3945300002010: A/C Power Brick
• B3945100004040: Custom Pouch for 2 WVSMs
• B3945100004030: Carry Case for 10 WVSMs
• B3945100004020: Carry Case for 4 WVSMs
• B3945100004010: Carry Case for 2 WVSMs
• B3945000025060: Carry case/Charger for 10 WVSMs - Graphite
• B3945000025050: Carry case/Charger for 10 WVSMs - Silver
• B3945000025040: Carry case/Charger for 10 WVSMs - Yellow
• B3945000025030: Carry case/Charger for 10 WVSMs - Orange
• B3945000025020: Carry case/Charger for 10 WVSMs - Olive
• B3945000025010: Carry case/Charger for 10 WVSMs - Black
• B3945000001120: Wireless Patient Monitor
• B3945000001010: Wireless Patient Monitor
• B3944670006010: A/C Power Cord
• B3944060005010: BP Cuff Clip
• B3943950006000: WVSM Management Suite - iOS
• B3943900004000: WVSM Management Suite - PC
• B3945300025010: AC/DC Power Supply
• B3944670036010: A/C Power Cord - Israel
• B3944670019020: A/C Power Cord
• B3945700047020: miniCap Sidestream
• B3945700047010: miniCap Mainstream
• B394530023020: WVSM Aux Battery (Angled)
• B3945300023010: WVSM Aux Battery (Straight)
• B3945000034040: Wireless Patient Monitor
• B3945000034030: Wireless Patient Monitor
• B3945000034020: Wireless Patient Monitor
• B3945000034010: Wireless Patient Monitor
• B3944670019010: WVSM Power Cord (US)
• B3944670063010: C13 AC Power Cord to European C7