Tempus LS-Manual

GUDID 05060472441959

Tempus LS-Manual Adult Electrodes

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Physiologic-monitoring defibrillation system

• Primary Device ID: 05060472441959
• NIH Device Record Key: c79c5f28-805b-487c-a616-64f52ef33eb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempus LS-Manual
• Version Model Number: 01-3020
• Company DUNS: 896707940
• Company Name: REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060472441959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200849

FDA Product Code

• LDD: Dc-Defibrillator, Low-Energy, (Including Paddles)

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: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [Tempus LS-Manual]

• 05060472441973: Tempus LS-Manual CPR Feedback Sensor
• 05060472441966: Tempus LS-Manual Securing Pads
• 05060472441959: Tempus LS-Manual Adult Electrodes
• 05060472441942: Tempus LS-Manual Paediatric Electrodes
• 05060472441539: Tempus LS Mount Claw Adapter Kit
• 05060472441423: Tempus LS Mount