Resp-O2 Compressor Nebulizer

GUDID 00840117319455

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117319455
• NIH Device Record Key: c2fb1cee-5ad0-458c-9d4d-17991f57a400
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Compressor Nebulizer
• Version Model Number: 34408
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117319448 [Package]; Package: Case [6 Units]; In Commercial Distribution
GS1	00840117319455 [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: 2022-05-19
• Device Publish Date: 2022-05-11

Devices Manufactured by DYNAREX CORPORATION

• 00840117340336 - Resp-O2 Nebulizer Tee Connector, Standard 22 mm x OD x 18 mm ID x 22 mm OD: 2025-10-07 Connections
• 00840117340428 - Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender: 2025-10-07
• 00616784150529 - Adhesive Tape Remover Pads, For Professional and Hospital Use: 2025-10-06
• 00810180842303 - Dynarex Skincote Protective Dressing Applicators, 1.25" x 2.68": 2025-10-06 (3.25 cm x 6.81 cm)
• 00616784191027 - DynaFit Graduated Compression Anti-Embolism Stocking,Small: 2025-10-06 Knee Moderate (15-20 MMHG) Compression
• 00616784191119 - DynaFit Graduated Compression Anti-Embolism Stocking, Medium Knee: 2025-10-06
• 00616784191218 - DynaFit Graduated Compression Anti-Embolism Stocking, Large Knee: 2025-10-06
• 00616784191317 - DynaFit Graduated Compression Anti-Embolism Stocking, X-Large Knee: 2025-10-06