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

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• 00810180842198 - LabChoice Petri Dishes, Stackable, 90 x 15 mm, Sterile: 2025-06-24 Sterile-EO
• 00810180842204 - LabChoice Petri Dishes, Stackable, Sterile, 150 x 15 mm: 2025-06-24 Sterile-EO
• 00810180842211 - LabChoice Sputum Containers, 40 mL: 2025-06-24 Non-Sterile
• 00810180842228 - DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 Gallon: 2025-06-24
• 00810180842235 - DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 Gallon: 2025-06-24
• 00810180842242 - DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 Gallon: 2025-06-24