Shuco S5000-EX

GUDID 40260720011696

Nebulizer

ALLIED HEALTHCARE PRODUCTS, INC.

Nebulizing system, non-heated

• Primary Device ID: 40260720011696
• NIH Device Record Key: a41d3beb-2289-4a2b-9bc5-047fa37d2e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shuco
• Version Model Number: S5000-EX
• Catalog Number: S5000-EX
• Company DUNS: 099674145
• Company Name: ALLIED HEALTHCARE PRODUCTS, INC.
• 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: 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	00260720011698 [Primary]
GS1	40260720011696 [Package]; Contains: 00260720011698; Package: case [6 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Shuco]

• 40260720011696: Nebulizer
• 00026072011690: Nebulizer