Bentely the Bear Pediatric Nebulizer

GUDID 00372217005049

Bentely the Bear Pediatric Nebulizer

ARISE MEDICAL LLC

Nebulizing system delivery set, reusable

• Primary Device ID: 00372217005049
• NIH Device Record Key: c0e3cbee-73bd-4a53-8116-2f3ff1cd70e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bentely the Bear Pediatric Nebulizer
• Version Model Number: 240486
• Company DUNS: 081149273
• Company Name: ARISE MEDICAL LLC
• 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: true
• 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	00372217005049 [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: 2019-05-10
• Device Publish Date: 2019-05-02

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