Tempus IC

GUDID 05060472440686

12-Lead ECG Harness

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Transportable physiologic monitoring system

• Primary Device ID: 05060472440686
• NIH Device Record Key: c14a093e-a35b-45b7-8e48-041ed01b1399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempus IC
• Version Model Number: 01-1010
• Company DUNS: 896707940
• Company Name: REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
• 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: 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	05060472440686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113105

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Tempus IC]

• 05060472440709: Consumables Replenishment Kit
• 05060472440693: Mains Power Supply
• 05060472440686: 12-Lead ECG Harness
• 05060472440679: 00-1001
• 05060472440600: Lo-Flo® Sidestream Capnometer