Soteria Neonatal Mattress Barrier

GUDID 00850045714536

Waterproof bed mattress cover, reusable

Primary Device ID	00850045714536
NIH Device Record Key	6b709882-5bb8-4fab-ba72-e17ac1f6ca42
Commercial Distribution Status	In Commercial Distribution
Brand Name	Soteria Neonatal Mattress Barrier
Version Model Number	Nara Standard NARSTD-0000
Company DUNS	078444470
Company Name	Trinity Guardion, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850045714512 [Primary]
GS1	00850045714536 [Package] Contains: 00850045714512 Package: Dispenser Box [10 Units] In Commercial Distribution

FMW	Cover, Mattress (Medical Purposes)

Steralize Prior To Use	false
Device Is Sterile	false

00850045714536 - Soteria Neonatal Mattress Barrier	2025-08-26
00850045714536 - Soteria Neonatal Mattress Barrier	2025-08-26
00850045714499 - Soteria Mattress Barrier	2025-07-31
00850045714505 - Soteria Mattress Barrier	2025-07-31
00850045714482 - Soteria Mattress Barrier	2025-07-24
00850045714468 - Soteria Mattress Barrier	2025-07-09
00850045714475 - Soteria Mattress Barrier	2025-07-09
00850045714451 - Soteria Mattress Barrier	2025-04-03
00850045714437 - Soteria Bed Barrier	2024-11-25