ProSim 8 3979409

GUDID 00850540007065

Vital Signs Patient Simulator

FLUKE ELECTRONICS CORPORATION

Multi-parameter device tester

• Primary Device ID: 00850540007065
• NIH Device Record Key: 20d6daf0-cec2-4fa0-85e0-d59696689eed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProSim 8
• Version Model Number: PROSIM 8
• Catalog Number: 3979409
• Company DUNS: 002687614
• Company Name: FLUKE ELECTRONICS CORPORATION
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850540007065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110429

FDA Product Code

• DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-24

Devices Manufactured by FLUKE ELECTRONICS CORPORATION

• 00850540007218 - ESA 614: 2019-04-12 Electrical Safety Analyzer
• 00850540007065 - ProSim 8: 2018-07-06Vital Signs Patient Simulator
• 00850540007065 - ProSim 8: 2018-07-06 Vital Signs Patient Simulator
• 00850540007072 - ProSim 4: 2018-07-06 Vital Signs Patient Simulator
• 00850540007089 - ProSim 2: 2018-07-06 Vital Signs Patient Simulator
• 00850540007096 - ProSim 3: 2018-07-06 Vital Signs Patient Simulator
• 00850540007102 - ProSim SPOT Light: 2018-07-06 SpO2 Pulse Oximeter Analyzer
• 00850540007119 - Impulse 6000D: 2018-07-06 Defibrillator Analyzer
• 00850540007133 - Impulse 4000: 2018-07-06 Defibrillator/Pacer Analyzer