Big Wedge Pillow

GUDID 06978959250057

Xiamen SeaWorld Houseware Co., Ltd.

Bed pillow, reusable
Primary Device ID06978959250057
NIH Device Record Keyca7639fb-a890-4c23-9ccd-783aaff8c8b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBig Wedge Pillow
Version Model NumberPXAB-000005
Company DUNS509456151
Company NameXiamen SeaWorld Houseware Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106978959250057 [Primary]

FDA Product Code

PWCGeneral Wellness Product

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-08
Device Publish Date2025-07-31

Devices Manufactured by Xiamen SeaWorld Houseware Co., Ltd.

06978959250040 - Bed Wedge Pillow (7 inch)2025-08-08
06978959250057 - Big Wedge Pillow2025-08-08
06978959250057 - Big Wedge Pillow2025-08-08
06978959250118 - Leg Elevation Pillow (CoolingGel)2025-08-08

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