ThermoSuit System 59002

GUDID 00851936007003

LIFE RECOVERY SYSTEMS HD LLC

Circulating-fluid whole-body cooling system control unit External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only External circulating-fluid core temperature regulation system control unit, cooling-only

• Primary Device ID: 00851936007003
• NIH Device Record Key: 4dfd401a-f569-4ccf-9991-edbe4cabac72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoSuit System
• Version Model Number: TSP-50 Pump/Controller
• Catalog Number: 59002
• Company DUNS: 825390458
• Company Name: LIFE RECOVERY SYSTEMS HD LLC
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851936007003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061023

FDA Product Code

• NZE: Hyperthermia Monitor

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: 2016-09-08

On-Brand Devices [ThermoSuit System]

• 00851936007119: Training Software
• 00851936007102: Pump/Controller Fill Hose
• 00851936007096: Temperature Cable
• 00851936007089: 18F Temperature Probe
• 00851936007072: Disposable Kit,Med.
• 00851936007065: Patch Kit
• 00851936007058: 12F Temperature Probe
• 00851936007041: Reservoir Liner
• 00851936007034: Top Sheet
• 00851936007027: Multi-lumen Umbilicus Hose
• 00851936007010: Pump Cassette Assembly
• 00851936007003: TSP-50 Pump/Controller
• 00851936007126: Activation Kit
• 08511936007126: Activation Kit
• 10851936007079: Disposable Kit, Case
• 08511936007010: TSP-50 Pump/Controller