Dynarex My Resp-O2 Penguin Compressor Nebulizer

GUDID 00840117308794

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117308794
• NIH Device Record Key: 2687a339-26e6-404e-bde4-837682b59fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dynarex My Resp-O2 Penguin Compressor Nebulizer
• Version Model Number: 34405
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	00840117308794 [Primary]
GS1	00840117308800 [Package]; Package: Case [4 Units]; In Commercial Distribution

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: 2021-01-27
• Device Publish Date: 2021-01-19

Devices Manufactured by DYNAREX CORPORATION

• 00840117340343 - Resp-O2 Disposable Guedel Airway, 40 mm, Newborn, Pink: 2024-12-09
• 00840117340510 - Resp-O2 Disposable Guedel Airway, 50 mm, Infant, Blue: 2024-12-09
• 00840117340527 - Resp-O2 Disposable Guedel Airway,60 mm, Toddler, Black: 2024-12-09
• 00840117340374 - Resp-O2 Disposable Guedel Airway, 70 mm, Child, White: 2024-12-09
• 00840117340381 - Resp-O2 Disposable Guedel Airway, 80 mm, Adult Small, Green: 2024-12-09
• 00840117338128 - Sharps Clean-Up Kit: 2024-11-26 Contents: Sharps Shaft, Pair of Gloves, Tweezers, BZK Towelette, Biohazard Bag, Twist Tie.
• 00810180840163 - DynaSafety Cotton-Tipped Applicators in Sealed Vial,3": 2024-11-19
• 00840117341210 - Medicine Cups 1oz: 2024-11-05