GOJJI MULTIFUNCTION (GLUC-KETONE) METER

GUDID 00850001462129

GOJJI, INC.

Glucose/ketone monitoring system IVD, home-use

• Primary Device ID: 00850001462129
• NIH Device Record Key: ed3a8dbf-adbc-4590-a5de-951851c7c6fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GOJJI MULTIFUNCTION (GLUC-KETONE) METER
• Version Model Number: V1
• Company DUNS: 006572586
• Company Name: GOJJI, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850001462129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173505

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-28
• Device Publish Date: 2020-04-20

On-Brand Devices [GOJJI MULTIFUNCTION (GLUC-KETONE) METER]

• 00850001462129: V1
• 00850001462112: V1