FDA.reportPublic FDA data

Soteria Bed Barrier

Primary DI
00850045714604
Brand
Soteria Bed Barrier
Company
Trinity Guardion, Inc.
Model
Linet Ave2 Head LINAVE-000H
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTVMattress And Bed Deck Cover (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTVMattress And Bed Deck Cover (Medical Purposes)General Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201876000Soteria Bed BarrierTrinity Guardion2022-09-01QTV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045714604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045714604008500457146048500457146040850045714604

GMDN Terms#

Term, Definition table
TermDefinition
Waterproof bed mattress cover, reusableA 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.

Contacts#

Phone, Email table
PhoneEmail
812-932-2600info@trinityguardion.com

Regulatory Flags#

DUNS number
078444470
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045714611Soteria Bed BarrierLinet Ave2 Foot LINAVE-000F2026-10-19
00850045714581Soteria Mattress BarrierHard Cribette HRD223-000S2026-03-10
00850045714574Soteria Mattress BarrierUniversal 84x35x8 843508-0M002026-01-15
00850045714567Soteria Mattress BarrierUniversal 84x35x8 843508-0E002025-12-08
00850045714529Soteria Neonatal Mattress BarrierAtom Bassinet ATMBAS-00002025-10-20
00850045714543Soteria Neonatal Mattress BarrierAtom Warmer ATMWRM-00002025-10-20
00850045714550Soteria Neonatal Mattress BarrierAtom Incubator ATMINC-00002025-10-20
00850045714512Soteria Neonatal Mattress BarrierNara Standard NARSTD-00002025-08-18
00850045714536Soteria Neonatal Mattress BarrierNara Standard NARSTD-00002025-08-18
00850045714499Soteria Mattress BarrierGynnie Stretcher Head STRGYN-000H2025-07-23
00850045714505Soteria Mattress BarrierGynnie Stretcher Foot STRGYN-000F2025-07-23
00850045714482Soteria Mattress BarrierUniversal 80x48x9 804809-A00S2025-07-16
00850045714468Soteria Mattress BarrierUniversal Stretcher STRU26-00002025-07-01
00850045714475Soteria Mattress BarrierUniversal Stretcher STRU30-00002025-07-01
00850045714451Soteria Mattress BarrierUniversal 75x38x6 753806-000S2025-03-26
00850045714437Soteria Bed BarrierUniversal 80x36x9 803609-A00S2024-11-15
00850045714444Soteria Bed BarrierUniversal 80x42x9 804209-A00S2024-11-15
00850045714413Soteria Bed BarrierCentrella Pro+ CENPRO-01002024-11-04
00850045714420Soteria Bed BarrierCentrella Max CENMAX-01002024-10-28
00850045714406Soteria Mattress BarrierUniversal Stretcher UNVST5-00002024-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045714611Soteria Bed BarrierTrinity Guardion, Inc.QTV2026-10-19
00850045714574Soteria Mattress BarrierTrinity Guardion, Inc.QTV2026-01-15
00850045714567Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-12-08
00850045714499Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-07-23
00850045714505Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-07-23
00850045714482Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-07-16
00850045714468Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-07-01
00850045714475Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-07-01
00850045714451Soteria Mattress BarrierTrinity Guardion, Inc.QTV2025-03-26
00850045714437Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-11-15
00850045714444Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-11-15
00850045714413Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-11-04
00850045714420Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-10-28
00850045714260Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
00850045714277Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
00850045714284Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
00850045714291Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
00850045714307Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
00850045714314Soteria Bed BarrierTrinity Guardion, Inc.QTV2024-04-11
06976639180014StarsleepShanghai Charme Health Technology Co., LtdQTV2023-09-28
00850045714024Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-04-10
00850045714246Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-04-10
00850045714253Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-04-10
00850045714031Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714130Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714208Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714215Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714222Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714239Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-28
00850045714000Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-13