GOJJI BLOOD PRESSURE WELCOME KIT

GUDID 00850001002011

GOJJI, INC.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 00850001002011
• NIH Device Record Key: 43484000-b92c-46c0-8a35-6a0d8e492b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GOJJI BLOOD PRESSURE WELCOME KIT
• 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	00850001002011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101926

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2020-12-31
• Device Publish Date: 2020-12-23

Devices Manufactured by GOJJI, INC.

• 00850001002011 - GOJJI BLOOD PRESSURE WELCOME KIT: 2020-12-31
• 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
• 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