Mask

GUDID 10709078014328

Mask Adult Tracheostomy

WESTMED, INC.

Aerosol face mask, non-rebreathing

• Primary Device ID: 10709078014328
• NIH Device Record Key: 8d9944ff-4c62-48b7-b6d8-ac3a1ee3615b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mask
• Version Model Number: 1002219
• Company DUNS: 092673953
• Company Name: WESTMED, 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078014321 [Primary]
GS1	10709078014328 [Package]; Contains: 00709078014321; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• BYG: Mask, Oxygen

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [Mask]

• 10709078014359: Mask Adult Aerosol Elongated
• 10709078014342: Mask Oxygen Adult W/7' Kink Resistant Tubing Standard Connector
• 10709078014335: Mask Pediatric Tracheostomy
• 10709078014328: Mask Adult Tracheostomy
• 10709078014311: Mask Adult Face Tent
• 10709078014304: Mask Aerosol Pediatric Vented W/O Tubing
• 10709078014298: Mask Adult Aerosol (Vented)
• 10709078014038: Mask Aerosol Pediatric Elongated Vented W/O Tubing