GOJJI LANCET 30G-GLUCOSE TEST STRIP

Basic Information

• Brand Name: GOJJI LANCET 30G-GLUCOSE TEST STRIP
• Primary DI: 00850001462396
• Version / Model: v1
• Company Name: GOJJI, INC.
• Labeler DUNS: 006572586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 420
• Record Status: Published
• Publish Date: 2020-04-08
• Public Version: 1
• Public Version Date: 2020-04-16
• Public Version Status: New
• Public Device Record Key: 776fe820-4577-4710-a699-83bb439e7c3a

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMK	Lancet, Blood	General, Plastic Surgery	878.4850	2
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001462396	GS1
Unit of Use	08500014623964	GS1