BLOOD GLUCOSE MONITORING SYSTEM (HanrayCare)

GUDID 04897137180011

Meter x1 Test Strip x100 Lancing Device x1 Sterile Lancet x100

Hongkong Uni-innovation Co., Limited

Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care Glucose analyser IVD, point-of-care

• Primary Device ID: 04897137180011
• NIH Device Record Key: e7f2c648-41a5-4ef2-a25a-d489c0c88fa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLOOD GLUCOSE MONITORING SYSTEM (HanrayCare)
• Version Model Number: TD-4125
• Company DUNS: 989065642
• Company Name: Hongkong Uni-innovation Co., Limited
• 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: 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	04897137180011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124040

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: 2024-05-01
• Device Publish Date: 2024-04-23