Lifogen 31-01-0600

GUDID 00260720011018

Emergency Oxygen Unit

ALLIED HEALTHCARE PRODUCTS, INC.

Fixed-regulator oxygen cylinder

• Primary Device ID: 00260720011018
• NIH Device Record Key: a1209da7-cf45-4e7c-8e67-e8d148d80318
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lifogen
• Version Model Number: 0022-230P
• Catalog Number: 31-01-0600
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00260720011018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895956

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Lifogen]

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