AccessGUDID - DEVICE: Calibrator A (07332699000461)

GUDID

Device Identifier (DI) Information

Brand Name: Calibrator A
Version or Model: Calibrator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P000057
Company Name: M DIALYSIS INC.

Primary DI Number: 07332699000461
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 824632087 *Terms of Use

Device Description: Calibrator for ISCUSflex Microdialysis Analyzer. Contains calibrator levels for Glucose, Lactate, Pyruvate, Glycerol and Glutamate.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
45467	Microdialysis system	An assembly of devices intended to be used to monitor local body-tissue chemistry for the early detection of metabolic imbalances and/or cell damage, typically after surgery or during a metabolic disorder. The assembly typically includes a dedicated catheter that is inserted/implanted into tissue (e.g., brain, liver, muscle), a pump that circulates perfusion fluid and interstitial fluid dialysate to and from the site of monitoring, a small vial(s) used to collect samples of dialysate, and an analyser used to determine and display concentrations of analytes (e.g., glucose, lactate, pyruvate) in dialysate samples.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, Primary

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fe8975d4-51e8-449f-a83c-a0a62bc81408
Public Version Date: October 07, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016