Recirculator

Primary DI
08719992086009
Brand
Recirculator
Company
Eight Medical International B.V.
Model
8.0
Device description
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.
Published
2020-04-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102900000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102900000HEITER 3000 HYPERTHERMIC PERFUSION SYSTEMHei, Inc.2012-03-21LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719992086009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719992086009087199920860098719992086009

GMDN Terms#

Term, Definition table
TermDefinition
Extravascular-circulation hyperthermia system applicator, intracorporealA component of a hyperthermia system that typically consists of catheter-enclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator's tubing for localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
490348632
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719992086016Lavage Procedure Kit12020-04-10

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Primary DI, Brand, Company table
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