Jay X2 E2622

GUDID 00016958056716

The JAY X2® is a lightweight, maintenance-free, fluid wheelchair cushion with a reduced profile that is designed to provide stability and pressure relief to active clients. Using elements from the JAY Xtreme and Active cushions, the X2 combines JAY’s time-tested designs with its latest technologies.

SUNRISE MEDICAL (US) LLC

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• Primary Device ID: 00016958056716
• NIH Device Record Key: af63b9f9-582f-4c33-97cc-ff9d8e8a3caf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jay X2
• Version Model Number: X2
• Catalog Number: E2622
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) LLC
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958056716 [Primary]

FDA Product Code

• IMP: Cushion, Wheelchair

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: 2023-09-13
• Device Publish Date: 2023-09-05

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