Tradeflex Max

GUDID 00854798000045

PIVOTAL HEALTH SOLUTIONS, INC.

Examination/treatment table, line-powered

• Primary Device ID: 00854798000045
• NIH Device Record Key: 25e13331-3301-4b10-834b-c3d1a26e75d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tradeflex Max
• Version Model Number: E9118
• Company DUNS: 826316098
• Company Name: PIVOTAL HEALTH SOLUTIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854798000045 [Primary]

FDA Product Code

• INQ: Table, Powered

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: 2023-08-29
• Device Publish Date: 2023-08-21

Devices Manufactured by PIVOTAL HEALTH SOLUTIONS, INC.

• 00854798000274 - THERA-PTX: 2024-07-24
• 00854798000281 - THERA-PTX: 2024-07-24
• 00850020142415 - Quantum Intersegmental Table: 2023-08-29
• 00850020142422 - Quantum Intersegmental Table, with Patient Assist: 2023-08-29
• 00854798000007 - Pelvic Health Table: 2023-08-29
• 00854798000038 - Essential Pelvic Health Table: 2023-08-29
• 00854798000045 - Tradeflex Max: 2023-08-29
• 00854798000045 - Tradeflex Max: 2023-08-29
• 00854798000052 - Tradeflex Max, Elevating: 2023-08-29