FDA.reportPublic FDA data

EIGHT MEDICAL CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099315383009931538EIGHT MEDICAL CORPORATION1N2020-04-25345 S. College Avenue Suite 103 Bloomington IN US 47403
30118318243011831824EIGHT MEDICAL INTERNATIONAL B.V.1N2020-04-25Gardermoenbaan 25 Rotterdam Zuid-Holland NL 3045AX

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2106581195253450K102900HEITER 3000 HYPERTHERMIC PERFUSION SYSTEMLGZ2012-03-21
1659871378422866K102900HEITER 3000 HYPERTHERMIC PERFUSION SYSTEMLGZ2012-03-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LGZ22012-03-21

GUDID#

Recirculator - 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.

2020-04-10