Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant

GUDID 00840117321687

Intended for use in anesthetic therapy

DYNAREX CORPORATION

Anaesthesia face mask, single-use

• Primary Device ID: 00840117321687
• NIH Device Record Key: 4eb58612-3630-4920-853d-96776d8c7861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant
• Version Model Number: 36031
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: 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	00840117321625 [Package]; Package: Case [20 Units]; In Commercial Distribution
GS1	00840117321687 [Primary]

FDA Product Code

• BSJ: Mask, Gas, Anesthetic

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: 2022-10-11
• Device Publish Date: 2022-10-03

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