Tempus IC2 867374

GUDID 05060472442949

Tempus IC2 Patient Monitor

REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED

Multiple vital physiological parameter monitoring system, clinical

• Primary Device ID: 05060472442949
• NIH Device Record Key: 2cb8f45b-8053-49a9-ad77-db306d14d030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tempus IC2
• Version Model Number: 00-2001-R
• Catalog Number: 867374
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060472440488 [Previous]
GS1	05060472442949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152124

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: 2022-09-16
• Device Publish Date: 2022-09-08

On-Brand Devices [Tempus IC2]

• 05060472440594: Tempus Lithium-ion Battery (Orange)
• 05060472440501: 00-2001-T
• 05060472440495: 00-2001-S
• 05060472440488: 00-2001-R
• 05060472440464: Tempus 12-Lead Electrocardiogram Harness
• 05060472440457: Glucometer Replenishment Kit
• 05060472440440: Consumables Replenishment Kit
• 05060472440433: 01-2506
• 05060472442949: Tempus IC2 Patient Monitor