FDA.reportPublic FDA data

Trinity Guardion, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30092765533009276553Trinity Guardion, Inc.1N2026-01-014 S Park Ave Suite 204 Batesville IN US 47006

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850045714512Soteria Neonatal Mattress Barrier - Nara Standard NARSTD-0000812-932-2600info@trinityguardion.com
00850045714529Soteria Neonatal Mattress Barrier - Atom Bassinet ATMBAS-0000812-932-2600info@trinityguardion.com
00850045714536Soteria Neonatal Mattress Barrier - Nara Standard NARSTD-0000812-932-2600info@trinityguardion.com
00850045714543Soteria Neonatal Mattress Barrier - Atom Warmer ATMWRM-0000812-932-2600info@trinityguardion.com
00850045714550Soteria Neonatal Mattress Barrier - Atom Incubator ATMINC-0000812-932-2600info@trinityguardion.com
00850045714567Soteria Mattress Barrier - Universal 84x35x8 843508-0E00812-932-2600info@trinityguardion.com
00850045714574Soteria Mattress Barrier - Universal 84x35x8 843508-0M00812-932-2600info@trinityguardion.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1301761683242075K201876Soteria Bed BarrierQTV2022-09-01
1301761566569989

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QTV12022-09-01

PMN#

GUDID#

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