My Penguin Compressor Nebulizer

GUDID 00840117300026

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117300026
• NIH Device Record Key: dea6573c-9646-4350-b7e2-eba5159a6302
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Penguin Compressor Nebulizer
• Version Model Number: 5608PN
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 4
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784560847 [Unit of Use]
GS1	00840117300026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043238

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: 2019-12-26
• Device Publish Date: 2019-12-18

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• 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