AccessGUDID - DEVICE: 106 Microdialysis Pump (07332699000034)

GUDID

Device Identifier (DI) Information

Brand Name: 106 Microdialysis Pump
Version or Model: 106
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P000003
Company Name: M DIALYSIS INC.

Primary DI Number: 07332699000034
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 824632087 *Terms of Use

Device Description: Microdialysis pump running at a fixed flow rate of 0.3 µL/min for optimal Microdialysis sampling. The pump is prepared with the Battery (07332699000058) and the 106 Syringe (07332699000072) filled with the Perfusion Fluid (07332699000263) and finally connected to the Microdialysis catheter. The 106 Microdialysis Pump is easy to operate. An initial flush is performed automatically. Flushes can be initiated manually if necessary.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45470	Microdialysis system pump	An electromechanical device intended to be used to create positive and/or negative pressure to circulate perfusion fluid and interstitial fluid dialysate to and from a monitoring site in a tissue (e.g., brain, liver, muscle), as part of a system used to monitor local tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, Monitoring, Intracranial Pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e148cb0-8b40-4b9c-9c10-84e86b555b4d
Public Version Date: November 29, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016