FDA.reportPublic FDA data

Soteria Neonatal Mattress Barrier

Primary DI
00850045714536
Brand
Soteria Neonatal Mattress Barrier
Company
Trinity Guardion, Inc.
Model
Nara Standard NARSTD-0000
Published
2025-08-18
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
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
00850045714536PackageGS110In Commercial Distribution
00850045714512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045714536008500457145368500457145360850045714536
00850045714512008500457145128500457145120850045714512

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
DM exempt
false
Premarket exempt
true
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
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
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
00850045714529Soteria Neonatal Mattress BarrierTrinity Guardion, Inc.FMW2025-10-20