ISCUSflex 8003295

GUDID 07332699000744

Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).

M DIALYSIS INC.

Microdialysis system analyser
Primary Device ID07332699000744
NIH Device Record Keyf026ada0-837e-4c85-a167-a8d8f7f1bbad
Commercial Distribution StatusIn Commercial Distribution
Brand NameISCUSflex
Version Model NumberClinical
Catalog Number8003295
Company DUNS824632087
Company NameM DIALYSIS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332699000607 [Primary]
GS107332699000744 [Direct Marking]

FDA Product Code

GWMDevice, Monitoring, Intracranial Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-07
Device Publish Date2016-09-24

Devices Manufactured by M DIALYSIS INC.

07332699000300 - Reagent Kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.
07332699000331 - Reagent Set A2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a
07332699000348 - Reagent Set B2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate m
07332699000355 - Reagent Set C2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette.
07332699000461 - Calibrator A2019-10-07 Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutama
07332699000744 - ISCUSflex2019-10-07Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
07332699000744 - ISCUSflex2019-10-07 Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysi
07332699000621 - L-P-G Reagent kit2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate.
07332699000546 - 70 Brain Microdialysis Catheter 60/10, 4/pkg2019-10-07 Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnel

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.