GOJJI KETONE CONTROL SOLUTION-L1

GUDID 00850001462419

GOJJI, INC.

Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Glucose/ketone monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use Multiple clinical chemistry analyte monitoring system IVD, home-use

• Primary Device ID: 00850001462419
• NIH Device Record Key: 04d84361-934e-4c27-8ad5-bab1225ee6e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GOJJI KETONE CONTROL SOLUTION-L1
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850001462419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161738

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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

Devices Manufactured by GOJJI, INC.

• 00850001002011 - GOJJI BLOOD PRESSURE WELCOME KIT: 2020-12-31
• 00850001462112 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER: 2020-04-28
• 00850001462129 - GOJJI MULTIFUNCTION (GLUC-KETONE) METER: 2020-04-28
• 00850001462402 - GOJJI GLUCOSE CONTROL SOLN-NORMAL: 2020-04-28
• 00850001462419 - GOJJI KETONE CONTROL SOLUTION-L1: 2020-04-28
• 00850001462419 - GOJJI KETONE CONTROL SOLUTION-L1: 2020-04-28
• 00850001462006 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT: 2020-04-16
• 00850001462037 - GOJJI MULTIFUNCTION (GLUC-KETONE) KT: 2020-04-16
• 00850001462105 - GOJJI LANCING DEVICE WITH CLEAR CAP: 2020-04-16