Portable Nebulizer

GUDID 00616784561738

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00616784561738
• NIH Device Record Key: 29dec07d-1424-4425-9283-3645aeb11609
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Nebulizer
• Version Model Number: 5617
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784561714 [Unit of Use]
GS1	00616784561738 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140237

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: 2019-09-17
• Device Publish Date: 2019-09-09

Devices Manufactured by DYNAREX CORPORATION

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• 00840117339057 - Durma+ Transparent Film Dressing, Frame Style, Sterile: 2024-12-23 Sterile-EO, Size: 2.36" x 2.75" (6 cm x 7 cm)
• 00840117339088 - Durma+ Transparent Film Dressing, Frame Style, 4" x 4.75" (10 cm x 12 cm ): 2024-12-23 Sterile-EO
• 00840117340213 - Overbed Table H Base, Silver Vein, Walnut: 2024-12-23
• 00840117340220 - Overbed Table, H Base, Silver Vein, Mahogany: 2024-12-23
• 00840117340237 - Overbed Table, H Base, Silver Vein, Oak: 2024-12-23
• 00840117340343 - Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink: 2024-12-09
• 00840117340510 - Resp-O2 Disposable Guedel Airway, 50 mm, Infant, Blue: 2024-12-09