Allied Healthcare Products Inc EPV200

GUDID 00026072000267

Ventilator, Portable W/AC

ALLIED HEALTHCARE PRODUCTS, INC.

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• Primary Device ID: 00026072000267
• NIH Device Record Key: 718fc237-eb0a-41cc-8387-45cb7401d015
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allied Healthcare Products Inc
• Version Model Number: EPV200
• Catalog Number: EPV200
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00026072000267 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090356

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-13
• Device Publish Date: 2015-11-20

On-Brand Devices [Allied Healthcare Products Inc]

• 00260720000289: Ventilator Portable w/AC Spanish
• 00260720000265: Ventilator, Portable W/AC
• 00260720000258: Ventilator Portable Battery Operated
• 00026072000281: Ventilator Portable w/AC Spanish
• 00026072000267: Ventilator, Portable W/AC
• 00026072000250: Ventilator Portable Battery Operated