FDA.reportPublic FDA data

Soteria Neonatal Mattress Barrier

Primary DI
00850045714529
Brand
Soteria Neonatal Mattress Barrier
Company
Trinity Guardion, Inc.
Model
Atom Bassinet ATMBAS-0000
Published
2025-10-20
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
FMWCover, Mattress (Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMWCover, Mattress (Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850045714526PackageGS110In Commercial Distribution
00850045714529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004571452610850045714526
00850045714529008500457145298500457145290850045714529

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
Premarket exempt
true
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
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
00850045714369Soteria Pediatric Mattress BarrierGiraffe Standard GIRSTD-00002024-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840828196291BED COVER-4X36X88-CEN PRO PLUS MAT TOP-PCURBELL MEDICAL PRODUCTS, INC.FMW2026-04-08
00850045714581Soteria Mattress BarrierTrinity Guardion, Inc.FMW2026-03-10
00840828195898BED COVER-4X36X84-PROGRESSA PULM TOP-PCCURBELL MEDICAL PRODUCTS, INC.FMW2026-01-20
00850056748292FORWARD APLS Litter GuardINTEGRATED MEDCRAFT LLCFMW2026-01-15
07640178061446CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061736CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061828CT Table CoverPearl Technology AGFMW2025-12-17
07640178061835CT Table CoverPearl Technology AGFMW2025-12-17
07640178061842CT Table CoverPearl Technology AGFMW2025-12-17
07640178061927CT Table CoverPearl Technology AGFMW2025-12-17
07640178061934CT Table CoverPearl Technology AGFMW2025-12-17
07640178061941CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061958CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061965CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061972CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061989CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178061996CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062009CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062016CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062023CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062030CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062047CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062054CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062061CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062184CT Table CoverPearl Technology AGFMW2025-12-17
07640178062191CT Table CoverPearl Technology AGFMW2025-12-17
07640178062207CT Gantry CoverPearl Technology AGFMW2025-12-17
07640178062214CT Table CoverPearl Technology AGFMW2025-12-17
00850056748315FORWARD APLS Surgery SoakerINTEGRATED MEDCRAFT LLCFMW2025-11-06
00850045714543Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20