Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing

GUDID 00840117345263

600 mL Reservoir Bag, Universal Connector

Dynarex Corporation

Non-rebreathing oxygen face mask

• Primary Device ID: 00840117345263
• NIH Device Record Key: 450b2010-fce8-427f-b929-9a285107a920
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Non-Rebreather Elongated Mask, Infant 7' (2.1m) Crush-Resistant Tubing
• Version Model Number: 33054U
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117345201 [Package]; Package: Case [50 Units]; In Commercial Distribution
GS1	00840117345263 [Primary]

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

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: 2025-06-09
• Device Publish Date: 2025-05-30