THERMA ZONE

GUDID 06975803355012

Shanghai Youwen Medical Technology Co.,Ltd.

Hot/cold therapy pack, reusable

• Primary Device ID: 06975803355012
• NIH Device Record Key: 1880bf4b-3a71-46f0-b354-bed2cb797483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THERMA ZONE
• Version Model Number: 003-30
• Company DUNS: 544496113
• Company Name: Shanghai Youwen Medical 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: true
• Serial Number: false
• 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	06975803355012 [Primary]

FDA Product Code

• IME: Pack, Hot Or Cold, Reusable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-17
• Device Publish Date: 2022-12-09

Devices Manufactured by Shanghai Youwen Medical Technology Co.,Ltd.

• 06975803350000 - Youwen: 2025-10-03 Youwen cold therapy hand pad
• 06975803350017 - Youwen: 2025-10-03 Youwen cold therapy knee pad
• 06975803350024 - Youwen: 2025-10-03 Youwen cold therapy shoulder pad
• 06975803350031 - Youwen: 2025-10-03 Youwen cold therapy head pad
• 06975803350048 - Youwen: 2025-10-03 Youwen cold therapy waist pad
• 06975803350055 - Youwen: 2025-10-03 Youwen cold therapy thigh pad
• 06975803350062 - Youwen: 2025-10-03 Youwen cold therapy hip pad
• 06975803350079 - Youwen: 2025-10-03 Youwen ice blanket