Glucose reagent

Basic Information

• Brand Name: Glucose reagent
• Primary DI: 07332699000652
• Version / Model: 5 x Reagent, 5 x Buffer
• Catalog Number: P000023
• Company Name: M DIALYSIS INC.
• Labeler DUNS: 824632087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d2aafb48-0645-4e12-b33a-e1b0a7bb7768

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07332699000652	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius