Compact Compressor Nebulizer

GUDID 00616784561639

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00616784561639
• NIH Device Record Key: e2b618ed-6ccf-4358-8900-87eac2929841
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compact Compressor Nebulizer
• Version Model Number: 5616
• 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	00616784561615 [Unit of Use]
GS1	00616784561639 [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: 2019-05-29
• Device Publish Date: 2019-05-21

Devices Manufactured by DYNAREX CORPORATION

• 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
• 00840117344150 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 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
• 00840117344167 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 10 FR (3.3 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1.
• 00840117344174 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 12 FR (4.0 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult/Pediatric CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1.
• 00840117344181 - Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 14 FR (4.6 mm),30.5 cm/12 in: 2026-01-13 Double Swivel Elbow (DSE), Tracheal, Adult CONTENTS: 1. Closed Suction Catheter (Adult/Pediatric), 1. MDI Adaptor, 1. 15 mm x 22