Smartest Persona II Multi Blood Glucose Monitoring System

GUDID 04712803564141

OK BIOTECH CO., LTD.

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 04712803564141
• NIH Device Record Key: c88d5e95-0434-4a56-b42e-04cb39804284
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smartest Persona II Multi Blood Glucose Monitoring System
• Version Model Number: 6276
• Company DUNS: 658796458
• Company Name: OK BIOTECH CO., LTD.
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712803564141 [Primary]
GS1	04712803566060 [Package]; Package: Can [1 Units]; In Commercial Distribution
GS1	04712803568095 [Package]; Package: Bottle [1 Units]; In Commercial Distribution
GS1	04712803569269 [Package]; Package: PSC [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133509

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: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by OK BIOTECH CO., LTD.

• 00852169003015 - Perfect 3 Multi Blood Glucose Test Strips: 2023-08-31
• 04712803564141 - Smartest Persona II Multi Blood Glucose Monitoring System: 2023-08-31
• 04712803564141 - Smartest Persona II Multi Blood Glucose Monitoring System: 2023-08-31
• 00193169642324 - TruePoint: 2019-01-03 Blood Glucose Test Strips
• 00193169642331 - TruePoint: 2019-01-03 Blood Glucose Test Strips
• 00193169642348 - TruePoint: 2019-01-03 Blood Glucose Test Strips
• 00193169642362 - TruePoint: 2019-01-03 Blood Glucose Test Strips
• 00193169642409 - TruePoint: 2019-01-03 Blood Glucose Test Strips
• 10193169642307 - TruePoint: 2018-10-29 Blood Glucose Test Strips