Hedy SofMask 410MW

GUDID D903410MW2

Procedure Mask

Hedy Canada

Surgical/medical face mask, single-use

• Primary Device ID: D903410MW2
• NIH Device Record Key: 2cf0de2b-f62f-4d37-a7f8-0210cce9f704
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hedy SofMask
• Version Model Number: 410MW
• Catalog Number: 410MW
• Company DUNS: 249482399
• Company Name: Hedy Canada
• Device Count: 50
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM
• Phone: 905.271.1523
• Email: HAMED@HEDYGS.COM

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D903410MW0 [Unit of Use]
HIBCC	D903410MW1 [Primary]
HIBCC	D903410MW2 [Package]; Contains: D903410MW1; Package: CASE [6 Units]; In Commercial Distribution

FDA Product Code

• FXX: Mask, Surgical

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: 2020-05-06
• Device Publish Date: 2018-11-23

Devices Manufactured by Hedy Canada

• D903410MB2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903410MG2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903410MP2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903410MW2 - Hedy SofMask: 2020-05-06Procedure Mask
• D903410MW2 - Hedy SofMask: 2020-05-06 Procedure Mask
• D903420HFB2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903420HFG2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903420HFP2 - Hedy SoftMask: 2020-05-06 Procedure Mask
• D903420HFW2 - Hedy SoftMask: 2020-05-06 Procedure Mask