Resp-O2 Compressor Nebulizer

GUDID 00840117319455

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117319455
• NIH Device Record Key: c2fb1cee-5ad0-458c-9d4d-17991f57a400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Compressor Nebulizer
• Version Model Number: 34408
• 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	00840117319448 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	00840117319455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091272

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2022-05-19
• Device Publish Date: 2022-05-11

Devices Manufactured by DYNAREX CORPORATION

• 00810180840781 - LabChoice Transfer Pipettes, Small Bulb, 3mL Transparent: 2025-01-03 Sterile-Eo
• 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