Merits P325 30200715

GUDID 00835246004556

Ultra P325 Base

Merits Health Products, Inc.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 00835246004556
• NIH Device Record Key: a0ca6e6c-b463-4484-a876-d5f57df114dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merits
• Version Model Number: P325 30200715
• Catalog Number: P325 30200715
• Company DUNS: 879307148
• Company Name: Merits Health 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00835246004556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113577

FDA Product Code

• ITI: Wheelchair, 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: 2024-10-10
• Device Publish Date: 2024-10-02

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