BIO-BELT

GUDID 00860163001555

RICHWAY & FUJI BIO INC.

Electric pad localized-body heating system

• Primary Device ID: 00860163001555
• NIH Device Record Key: 6068a81c-14af-4341-865e-117619a4c3ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-BELT
• Version Model Number: 7000MX
• Company DUNS: 080311325
• Company Name: RICHWAY & FUJI BIO INC.
• 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: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860163001555 [Primary]

FDA Product Code

• IRT: Pad, Heating, Powered

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: 2025-06-24
• Device Publish Date: 2025-06-16

Devices Manufactured by RICHWAY & FUJI BIO INC.

• 00860163001517 - BIOMAT QUEEN: 2025-06-24
• 00860163001524 - BIOMAT PROFESSIONAL: 2025-06-24
• 00860163001531 - BIOMAT SINGLE: 2025-06-24
• 00860163001548 - BIOMAT MINI: 2025-06-24
• 00860163001555 - BIO-BELT: 2025-06-24
• 00860163001555 - BIO-BELT: 2025-06-24
• 00860163001500 - BIOMAT: 2020-04-28