Big Wedge Pillow

Basic Information

• Brand Name: Big Wedge Pillow
• Primary DI: 06978959250057
• Version / Model: PXAB-000005
• Company Name: Xiamen SeaWorld Houseware Co., Ltd.
• Labeler DUNS: 509456151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-31
• Public Version: 1
• Public Version Date: 2025-08-08
• Public Version Status: New
• Public Device Record Key: ca7639fb-a890-4c23-9ccd-783aaff8c8b7

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PWC	General Wellness Product	Unknown		N

GMDN Terms

Code	Name	Definition	Implantable	Status
15593	Bed pillow, reusable	A sealed fabric case (e.g., cotton, pure wool) stuffed with soft material (e.g., down, polyester, foam, buckwheat husks) designed to support the head especially during rest and sleep in bed; it can also be used to support another part of the body to provide comfort (e.g., behind the back when in a sitting position, under a leg for support). It may or may not be used with a pillowcase and is laundered for cleaning between periods of use. It does not include antimicrobial/probiotic materials but might provide a physical barrier (e.g., tight weave) to dust mites; it is not dedicated to specialized applications/therapies. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06978959250057	GS1