Thermo Cell

GUDID 06973843221120

For the detail information, please refer to the IFU.

Hangzhou Bioer Technology Co., Ltd.

Heating block IVD

• Primary Device ID: 06973843221120
• NIH Device Record Key: 71e054c9-d7bf-4744-95c1-7d80375a7919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermo Cell
• Version Model Number: HB-201
• Company DUNS: 545256935
• Company Name: Hangzhou Bioer Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	06973843221120 [Primary]

FDA Product Code

• JRG: Block, Heating

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: 2025-02-19
• Device Publish Date: 2025-02-11

On-Brand Devices [Thermo Cell]

• 06973843221137: For the detail information, please refer to the IFU.
• 06973843221120: For the detail information, please refer to the IFU.