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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• 00840117348813 - Unflavored Oral Swab, For Professional and Hospital Use: 2026-01-29 Individually Wrapped
• 00840117348837 - Oral Swabsticks, Flavored w/Dentrifice: 2026-01-29
• 00840117348851 - Unflavored Oral Swabs, For Professional and Hospital Use: 2026-01-29
• 00810180842440 - Exam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13
• 00810180842457 - Exam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Universal: 2026-01-13
• 00840117344136 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter,30.5 cm/12in, 12 FR (4.0 mm): 2026-01-13 STERILE-EO, CONTENT: 1. Catheter, 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22 mm Flex Tube, 1. 15 mm x 22 mm Adaptor, 1. Tra
• 00840117344143 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in: 2026-01-13 T-Piece, Tracheal, Adult, STERILE-EO CONTENT: 1. Closed Suction Catheter (Adult), 1. MDI Adaptor, 1. 15 mm Swivel Adaptor, 1. 22