Soteria Neonatal Mattress Barrier

Basic Information

• Brand Name: Soteria Neonatal Mattress Barrier
• Primary DI: 00850045714529
• Version / Model: Atom Bassinet ATMBAS-0000
• Company Name: Trinity Guardion, Inc.
• Labeler DUNS: 078444470
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-20
• Public Version: 1
• Public Version Date: 2025-10-28
• Public Version Status: New
• Public Device Record Key: 5598d203-274b-4a52-85d1-ea6224f263a6

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: Yes
• Has Lot/Batch Number: No
• 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
FMW	Cover, Mattress (Medical Purposes)	General Hospital	880.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37455	Waterproof bed mattress cover, reusable	A device made of soft, waterproof material that is shaped to fit over a bed mattress to create a physical barrier to protect the mattress, prevent cross-contamination, and prevent exposure to soiling, typically bedwetting or spills of other liquids. It can be laundered for cleaning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850045714529	GS1
Package	10850045714526	GS1	Dispenser Box	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]