Lifogen 31-10-6515

GUDID 00260720012114

Kit, Soft-Case

ALLIED HEALTHCARE PRODUCTS, INC.

Respiratory oxygen therapy system

• Primary Device ID: 00260720012114
• NIH Device Record Key: 52374fbe-ef35-4478-8f8a-590a6499aab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifogen
• Version Model Number: 31-10-6515
• Catalog Number: 31-10-6515
• 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: true
• 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	00260720012114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802644

FDA Product Code

• CAN: Regulator, Pressure, Gas Cylinder

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: 2019-07-12
• Device Publish Date: 2016-09-07

On-Brand Devices [Lifogen]

• 00260720012114: Kit, Soft-Case
• 00260720011018: Emergency Oxygen Unit
• 00026072011010: Emergency Oxygen Unit
• 00026072012116: Kit, Soft-Case