NICaS

GUDID 07290015331005

Bioimpedance Cardiac Analyzing Measuring System

NEW N.I. MEDICAL (2011) LTD

Impedance cardiograph

• Primary Device ID: 07290015331005
• NIH Device Record Key: 1cbb66a0-6ea4-4706-b0eb-a6c95cbe0448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NICaS
• Version Model Number: CS
• Company DUNS: 600279405
• Company Name: NEW N.I. MEDICAL (2011) LTD
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015331005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080941

FDA Product Code

• DSB: Plethysmograph, Impedance

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: 2023-05-05
• Device Publish Date: 2023-04-27