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

• 00840117340718 - Biopsy Punch, Sterile, 3.0 mm Grey: 2025-04-08 STERILE-R
• 00840117340725 - Biopsy Punches, Sterile, 3.5 mm, Yellow: 2025-04-08 STERILE-R
• 00840117340732 - Biopsy Punches, Sterile, 4.0 mm, Blue: 2025-04-08 STERILE-R
• 00840117340862 - Biopsy Punches, Sterile, 5.0 mm, Pink: 2025-04-08 STERILE-R
• 00840117340879 - Biopsy Punches, Sterile, 6.0 mm, Light Green: 2025-04-08 STERILE-R
• 00840117340923 - Biopsy Punches, Sterile, 8.0 mm, Purple: 2025-04-08
• 00840117340930 - Biopsy Punches, Sterile, Mixed Box: 2025-04-08 Biopsy Punches, Sterile, Mixed Box, 5 each of 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm
• 00810180841665 - LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile: 2025-04-07