Infant Oxygen Mask

GUDID 10709078012508

Infant Oxygen Mask with 8' KROT

WESTMED, INC.

Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing Aerosol face mask, non-rebreathing

• Primary Device ID: 10709078012508
• NIH Device Record Key: a02e7617-13ba-4da8-8c88-227fa6c61b82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Oxygen Mask
• Version Model Number: 3262-E
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078012501 [Primary]
GS1	10709078012508 [Package]; Contains: 00709078012501; 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: 2021-01-07
• Device Publish Date: 2020-12-30

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