Stasis Labs

GUDID 00854271008001

Stasis Monitor

STASIS LABS, INC.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00854271008001
• NIH Device Record Key: 2970c662-787e-47b2-bf41-51a02d838c55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stasis Labs
• Version Model Number: Stasis Monitoring System
• Company DUNS: 042605049
• Company Name: STASIS LABS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com
• Phone: 1.740.478.2747
• Email: contact@stasislabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854271008001 [Primary]
GS1	10854271008008 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183634

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: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-10-23