Celbrea TMD WC0010

GUDID B737WC0010

Breast Thermal Activity Indicator

WELWAZE MEDICAL INC

Liquid-crystal thermography system

• Primary Device ID: B737WC0010
• NIH Device Record Key: 6e094393-8f8c-4b3a-b570-609942a0d217
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celbrea TMD
• Version Model Number: WC0010
• Catalog Number: WC0010
• Company DUNS: 081093113
• Company Name: WELWAZE MEDICAL INC
• Device Count: 1
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com
• Phone: +1(786)537-6183
• Email: francis@welwaze.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B737WC0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832989

FDA Product Code

• KYA: System, thermographic, liquid crystal, nonpowered (adjunctive use)

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: 2023-02-24
• Device Publish Date: 2023-02-16