Bionime

GUDID 10810011730431

Tianjin Huahong Technology Co., Ltd.

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.

• 10810011730554 - BKG: 2024-11-01
• 50810011730569 - GLUCORACYIK: 2024-11-01
• 10810011730530 - Pro Comfort: 2024-09-03
• 10810011730547 - Pro Comfort: 2024-09-03
• 10810011730493 - Huahong: 2024-01-24
• 10810011730509 - Medhome: 2024-01-24
• 10810011730516 - Medhome: 2024-01-24
• 50810011730477 - Seren Guard: 2023-11-15