Trinity Guardion, Inc.

FDA Device Registration & Listing · Batesville, IN, US · Registration 3009276553

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009276553
FEI Number
3009276553
Entity Name
Trinity Guardion, Inc.
City/State/Country
Batesville, IN, US
Establishment Address
4 S Park Ave Suite 204, Batesville, IN 47006, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Trinity Guardion, Inc (Owner Number: 10037075)
Owner / Operator Contact Address
Four South Park Ave, Suite 204, Batesville, IN 47006, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201876
PMA Number
N/A

All Registered Proprietary Names

Soteria Bed Barrier Trinity Guardion

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QTV Mattress And Bed Deck Cover (Medical Purposes) General Hospital Class 1 880.6190 2023-03-03

Official Correspondent

Bruce Rippe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Trinity Guardion, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009276553. Last updated year: 2026. Please use registration number 3009276553 when referencing this establishment in official correspondence.
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