Recirculator

GUDID 08719992086009

The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics. The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The Recirculator 8.0 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.

Eight Medical International B.V.

Extravascular-circulation hyperthermia system applicator, intracorporeal Extravascular-circulation hyperthermia system applicator, intracorporeal

• Primary Device ID: 08719992086009
• NIH Device Record Key: 6bb30165-5f1c-4752-9ab5-d966409a0aa1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Recirculator
• Version Model Number: 8.0
• Company DUNS: 490348632
• Company Name: Eight Medical International B.V.
• 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	08719992086009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102900

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2020-04-20
• Device Publish Date: 2020-04-10

Devices Manufactured by Eight Medical International B.V.

• 08719992086009 - Recirculator: 2020-04-20The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consists of a heater, pump, user touch screen, microprocessor, and interface electronics. The primary user interface is a color touch screen display that allows the user to make selections from the operating screen consisting of message display area, main screen area and flow control area. The touch screen also displays operating conditions, flow rate, output fluid temperature, patient temperature, target temperature, alarm and status messages, various timers and auxiliary temperatures. The Recirculator 8.0 monitors various sensors in the fluid path to ensure safe operation and alerts the user with alarms for out of specification conditions. Independent protection circuits prevent unsafe operation in the event of system software fault. The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.
• 08719992086009 - Recirculator: 2020-04-20 The Recirculator 8.0 is comprised of two components: a portable control console and a single use disposable. The Console consi
• 08719992086016 - Lavage Procedure Kit: 2020-04-20 The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The