Soteria Pediatric Mattress Barrier

GUDID 00850045714369

Trinity Guardion, Inc.

Waterproof bed mattress cover, reusable
Primary Device ID00850045714369
NIH Device Record Keycbff792a-0142-4c0e-bd1d-e2e364b51eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoteria Pediatric Mattress Barrier
Version Model NumberGiraffe Standard GIRSTD-0000
Company DUNS078444470
Company NameTrinity Guardion, Inc.
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 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
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com
Phone812-932-2600
Emailinfo@trinityguardion.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850045714369 [Primary]
GS100850045714376 [Package]
Package: Dispenser Box [10 Units]
In Commercial Distribution
GS100850045714383 [Package]
Contains: 00850045714376
Package: Shipping Carton - 20 [2 Units]
In Commercial Distribution
GS100850045714390 [Package]
Contains: 00850045714376
Package: Shipping Carton - 40 [4 Units]
In Commercial Distribution

FDA Product Code

FMWCover, Mattress (Medical Purposes)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-21
Device Publish Date2024-05-13

On-Brand Devices [Soteria Pediatric Mattress Barrier]

00850045714369Giraffe Standard GIRSTD-0000
00850045714321Universal Pediatric 26191X-0000

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