Leg Elevation Pillow (CoolingGel)

GUDID 06978959250118

Xiamen SeaWorld Houseware Co., Ltd.

Bed pillow, reusable

• Primary Device ID: 06978959250118
• NIH Device Record Key: fcf20028-60b9-46b6-a443-9854effd6cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leg Elevation Pillow (CoolingGel)
• Version Model Number: PXAB-000011
• Company DUNS: 509456151
• Company Name: Xiamen SeaWorld Houseware Co., Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	06978959250118 [Primary]

FDA Product Code

• PWC: General Wellness Product

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: 2025-08-08
• Device Publish Date: 2025-07-31

Devices Manufactured by Xiamen SeaWorld Houseware Co., Ltd.

• 06978959250040 - Bed Wedge Pillow (7 inch): 2025-08-08
• 06978959250057 - Big Wedge Pillow: 2025-08-08
• 06978959250118 - Leg Elevation Pillow (CoolingGel): 2025-08-08
• 06978959250118 - Leg Elevation Pillow (CoolingGel): 2025-08-08