Resp-O2 Suction Unit With Base

GUDID 00840117309623

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

DYNAREX CORPORATION

Emergency airway clearance suction pump, electric

• Primary Device ID: 00840117309623
• NIH Device Record Key: 8db56e02-21fb-482d-9df4-0f43b79e9f31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Suction Unit With Base
• Version Model Number: 32301
• 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: false
• 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	00840117309623 [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

Devices Manufactured by DYNAREX CORPORATION

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• 00810180840798 - LabChoice Serological Pipettes, 1mL, Sterile: 2025-01-02 Sterile-R
• 00810180840804 - LabChoice Serological Pipettes, 2mL, Sterile: 2025-01-02 Sterile-R
• 00810180840811 - LabChoice Serological Pipettes, 5mL, Sterile: 2025-01-02 Sterile-R
• 00810180840774 - LabChoice Transfer Pipettes, Small Bulb, 3mL: 2025-01-02 Non-Sterile
• 00840117340398 - Resp-O2 Disposable Guedel Airway, 90 mm, Adult Medium, Yellow: 2024-12-30
• 00840117340404 - Resp-O2 Disposable Guedel Airway, 100 mm, Adult Large, Red: 2024-12-30
• 00840117340411 - Resp-O2 Disposable Guedel Airway, 110 mm, Adult X-Large, Orange: 2024-12-30