HomeFill® Oxygen System HF2PC9

GUDID 00850018761352

VENTEC LIFE SYSTEMS, INC.

Oxygen refillable cylinder

• Primary Device ID: 00850018761352
• NIH Device Record Key: bd127e9d-8c99-47bd-962d-d443f19a49ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HomeFill® Oxygen System
• Version Model Number: HF2PC9
• Catalog Number: HF2PC9
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018761352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021685

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [HomeFill® Oxygen System]

• 00850018761376: HF2POSTD
• 00850018761369: HF2POST9
• 00850018761352: HF2PC9
• 00850018761307: IOH200