Hippo Pediatric Nebulizer

GUDID 00616784560731

DYNAREX CORPORATION

Nebulizing system, non-heated

• Primary Device ID: 00616784560731
• NIH Device Record Key: 897f3ed6-4516-4d6c-8788-1ff5842443d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hippo Pediatric Nebulizer
• Version Model Number: 5607
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 6
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784560717 [Unit of Use]
GS1	00616784560731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140237

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: 2019-07-05
• Device Publish Date: 2019-06-27

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