Soteria Mattress Barrier

GUDID 00850045714451

Trinity Guardion, Inc.

Waterproof bed mattress cover, reusable
Primary Device ID00850045714451
NIH Device Record Key567c7450-9615-4bb5-8848-c58e48e4759a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoteria Mattress Barrier
Version Model NumberUniversal 75x38x6 753806-000S
Company DUNS078444470
Company NameTrinity Guardion, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045714451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QTVMattress And Bed Deck Cover (Medical Purposes)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-03
Device Publish Date2025-03-26

On-Brand Devices [Soteria Mattress Barrier]

008500457144065" Version
00850045714451Universal 75x38x6 753806-000S

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.