Allied Healthcare Products, Inc. D81

GUDID 00260720000180

Ventilator, Omni-Vent, D-8 MRI compatible control unit.

ALLIED HEALTHCARE PRODUCTS, INC.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 00260720000180
• NIH Device Record Key: 0cbe04de-cfb6-4029-95b0-5d4219b60f83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allied Healthcare Products, Inc.
• Version Model Number: 0V000001
• Catalog Number: D81
• Company DUNS: 099674145
• Company Name: ALLIED HEALTHCARE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00260720000180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872113

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

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: 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.