Allied healthcare Products, Inc. L063-240

GUDID 00026072000540

Demand Valve.

ALLIED HEALTHCARE PRODUCTS, INC.

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• Primary Device ID: 00026072000540
• NIH Device Record Key: f3e15f40-501a-455b-9384-33590c42ff9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allied healthcare Products, Inc.
• Version Model Number: L063-240
• Catalog Number: L063-240
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00026072000540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915564

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.]

• 00260720000616: Portable Assy.
• 00260720000548: Demand Valve.
• 00260720000500: Demand Valve Japan.
• 00260720000180: Ventilator, Omni-Vent, D-8 MRI compatible control unit.
• 00260720000074: Transport ventilator with internal compressor.
• 00026072000618: Portable Assy.
• 00026072000540: Demand Valve.
• 00026072000502: Demand Valve Japan.
• 00026072000182: Ventilator, Omni-Vent, D-8 MRI compatible control unit.
• 00026072000076: Transport ventilator with internal compressor.