Microvial rack 12/pkg P000028

GUDID 07332699000249

M DIALYSIS INC.

Microdialysis system
Primary Device ID07332699000249
NIH Device Record Keyaf43de14-ffee-4eef-86b2-b2200b77407c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrovial rack 12/pkg
Version Model NumberRack
Catalog NumberP000028
Company DUNS824632087
Company NameM DIALYSIS INC.
Device Count12
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107332699000249 [Primary]
GS107332699001000 [Unit of Use]

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 Number2
Public Version Date2018-03-29
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 - ISCUSflex2019-10-07 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.