Bionime

GUDID 10810011730431

Tianjin Huahong Technology Co., Ltd.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 10810011730431
• NIH Device Record Key: 21ffc788-408e-4baf-8ffd-0b4ffe25b89c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bionime
• Version Model Number: IC,30G
• Company DUNS: 421272490
• Company Name: Tianjin Huahong Technology Co., Ltd.
• Device Count: 100
• 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: true
• 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	00810011730434 [Primary]
GS1	10810011730431 [Package]; Contains: 00810011730434; Package: case [5000 Units]; In Commercial Distribution
GS1	50810011730439 [Unit of Use]

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Tianjin Huahong Technology Co., Ltd.

• 10810011730493 - Huahong: 2024-01-24
• 10810011730509 - Medhome: 2024-01-24
• 10810011730516 - Medhome: 2024-01-24
• 50810011730477 - Seren Guard: 2023-11-15
• 16957138606400 - Lite Touch: 2023-10-16
• 00810011730441 - Huahong: 2023-08-24
• 50810011730453 - HMD: 2023-08-24
• 50810011730460 - HMD: 2023-08-24