Perfect 3 Multi Blood Glucose Test Strips

GUDID 00852169003015

OK BIOTECH CO., LTD.

Glucose IVD, kit, electrometry

• Primary Device ID: 00852169003015
• NIH Device Record Key: 1f06b58d-bcf5-48db-87e2-6fa04507cb62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfect 3 Multi Blood Glucose Test Strips
• Version Model Number: OK1M
• Company DUNS: 658796458
• Company Name: OK BIOTECH CO., LTD.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.
• Special Storage Condition, Specify: Between 0 and 0 *Special Storage Condition, Specify: Store in a dry place between 39.2°F - 104°F (4°C - 40°C) and 10% - 85% R.H.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852169003015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122525

FDA Product Code

• CGA: Glucose Oxidase, Glucose

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
• 00852169003015 - Perfect 3 Multi Blood Glucose Test Strips: 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