LifeWindow

Basic Information

• Brand Name: LifeWindow
• Primary DI: 00860003504017
• Version / Model: LW8 Lite
• Company Name: DIGICARE BIOMEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 929404648
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-14
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: aa414258-6ab1-45d2-9132-ea8090ceb791

Device Description

Multi-Parameter Physiological Patient Monitor

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active
35569	Neonatal multi-parameter bedside monitor	A device/device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG), respiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation. The system typically includes sensors with appropriate size and design for infant use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003504017	GS1

Premarket Submissions

Submission Number	Supplement Number
K183687	000