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Product codes
QTV
Product code QTV
Device name
Mattress And Bed Deck Cover (Medical Purposes)
Medical specialty
General Hospital
Device class
1
Regulation number
880.6190
Review panel
HO
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K201876
Soteria Bed Barrier
Trinity Guardion
2022-09-01
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
00850045714574
Soteria Mattress Barrier
Trinity Guardion, Inc.
2026-01-15
00850045714567
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-12-08
00850045714499
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-07-23
00850045714505
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-07-23
00850045714482
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-07-16
00850045714475
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-07-01
00850045714468
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-07-01
00850045714451
Soteria Mattress Barrier
Trinity Guardion, Inc.
2025-03-26
00850045714444
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-11-15
00850045714437
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-11-15
00850045714413
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-11-04
00850045714420
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-10-28
00850045714260
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
00850045714277
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
00850045714284
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
00850045714291
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
00850045714307
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
00850045714314
Soteria Bed Barrier
Trinity Guardion, Inc.
2024-04-11
06976639180014
Starsleep
Shanghai Charme Health Technology Co., Ltd
2023-09-28
00850045714024
Soteria Bed Barrier
Trinity Guardion, Inc.
2023-04-10
00850045714246
Soteria Bed Barrier
Trinity Guardion, Inc.
2023-04-10
00850045714253
Soteria Bed Barrier
Trinity Guardion, Inc.
2023-04-10
00850045714031
Soteria Bed Barrier
Trinity Guardion, Inc.
2023-03-28
00850045714130
Soteria Bed Barrier
Trinity Guardion, Inc.
2023-03-28
00815067043613
MERIDIAN
Drive Devilbiss Healthcare
2021-01-15
00815067043279
MERIDIAN
Drive Devilbiss Healthcare
2020-02-28
00815067043224
MERIDIAN
Drive Devilbiss Healthcare
2020-02-28
00815067043156
MERIDIAN
Drive Devilbiss Healthcare
2020-02-28
00815067043415
MERIDIAN
Drive Devilbiss Healthcare
2017-02-09
00815067043408
MERIDIAN
Drive Devilbiss Healthcare
2017-02-09