LifeWindow

GUDID 00860003504017

Multi-Parameter Physiological Patient Monitor

DIGICARE BIOMEDICAL TECHNOLOGY, INC.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 00860003504017
• NIH Device Record Key: aa414258-6ab1-45d2-9132-ea8090ceb791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeWindow
• Version Model Number: LW8 Lite
• Company DUNS: 929404648
• Company Name: DIGICARE BIOMEDICAL TECHNOLOGY, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003504017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183687

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-22
• Device Publish Date: 2020-10-14