Microvials in rack, Sterile 12x4 P000154

GUDID 07332699000645

M DIALYSIS INC.

Microdialysis system

• Primary Device ID: 07332699000645
• NIH Device Record Key: 9c9ce31b-631e-4387-ba17-0b44eeda4261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microvials in rack, Sterile 12x4
• Version Model Number: Sterile
• Catalog Number: P000154
• Company DUNS: 824632087
• Company Name: M DIALYSIS INC.
• Device Count: 4
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332699000645 [Primary]
GS1	07332699000980 [Unit of Use]

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by M DIALYSIS INC.

• 07332699000300 - Reagent Kit: 2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol.
• 07332699000331 - Reagent Set A: 2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate and Glycerol mounted in a
• 07332699000348 - Reagent Set B: 2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate, Pyruvate, Glycerol and Glutamate m
• 07332699000355 - Reagent Set C: 2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate mounted in a cassette.
• 07332699000461 - Calibrator A: 2019-10-07 Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutama
• 07332699000744 - ISCUSflex: 2019-10-07 Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysi
• 07332699000621 - L-P-G Reagent kit: 2019-10-07 Reagents and Calibrator A for the ISCUSflex analyzer. Contains reagents for Glucose, Lactate and Pyruvate.
• 07332699000546 - 70 Brain Microdialysis Catheter 60/10, 4/pkg: 2019-10-07 Microdialysis catheter (20 kDa cut-off, 60 mm shaft length, 10 mm membrane length) for short term brain insertion using a tunnel