Resp-O2 Elite Compressor Nebulizer, Adult/Pediatric

GUDID 00840117308695

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00840117308695
• NIH Device Record Key: 4d9cff0f-7fc8-40e0-92f0-2f2d7ca46649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resp-O2 Elite Compressor Nebulizer, Adult/Pediatric
• Version Model Number: 34400
• 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	00840117308695 [Primary]
GS1	00840117308701 [Package]; Package: Case [4 Units]; In Commercial Distribution

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

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