Resp-O2 Suction Unit

GUDID 00840117309609

Resp-O2 Suction Unit, Vacuum Levels up to 560 mmHg

DYNAREX CORPORATION

Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric Emergency airway clearance suction pump, electric

• Primary Device ID: 00840117309609
• NIH Device Record Key: 0eac6261-0996-4a28-acae-aa0a110667ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Suction Unit
• Version Model Number: 32300
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00840117309609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042349

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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: 2022-05-17
• Device Publish Date: 2022-05-09

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