FDA.reportPublic FDA data

Soteria Bed Barrier

Primary DI
00850045714048
Brand
Soteria Bed Barrier
Company
Trinity Guardion, Inc.
Model
Progressa Therapy PRGTHP-0110
Published
2023-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850045714048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045714048008500457140488500457140480850045714048

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
078444470
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850045714321Soteria Pediatric Mattress BarrierUniversal Pediatric 26191X-00002024-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850045714017Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-13