SecureFoam 5038

GUDID 10714646001211

SecureFoam - Large

Bionix, LLC

Radiological whole-body positioner

• Primary Device ID: 10714646001211
• NIH Device Record Key: 50c16cad-3161-40b5-a09c-d4595a9d08a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureFoam
• Version Model Number: 5038
• Catalog Number: 5038
• Company DUNS: 117844489
• Company Name: Bionix, LLC
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• 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

Customer Support Contacts

• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00714646001214 [Primary]
GS1	10714646001211 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040773

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [SecureFoam]

• 10714646001242: SecureFoam - SAMPLE Large Box
• 10714646001235: SecureFoam - SAMPLE Medium
• 10714646001228: SecureFoam - SAMPLE Small
• 10714646001211: SecureFoam - Large
• 10714646001204: SecureFoam - Medium
• 10714646001198: SecureFoam - Small