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

Devices Manufactured by DYNAREX CORPORATION

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• 00810180841580 - LabChoice Rigid Inoculation Loops, Blue, Sterile, 10ul: 2025-03-31 STERILE-R
• 00810180841597 - LabChoice Flexible Inoculation Loops, Blue, Sterile, 10 ul: 2025-03-31 STERILE-R
• 00840117340688 - Biopsy Punch, Sterile, 1.5 mm ,White: 2025-03-28
• 00840117340695 - Biopsy Punch, Sterile, 2.0 mm, Ivory: 2025-03-28
• 00840117340701 - Biopsy Punch, Sterile, 2.5 mm, Green: 2025-03-28
• 00810180841566 - LabChoice Rigid Inoculation Loops, Transparent, Sterile, 1 ul: 2025-03-24 STERILE-R
• 00810180841573 - LabChoice Flexible Inoculation Loops, White, Sterile, 1 uL: 2025-03-24