FDA.reportPublic FDA data

Starsleep

Primary DI
06976639180014
Brand
Starsleep
Company
Shanghai Charme Health Technology Co., Ltd
Model
Mattress and bed deck cover
Published
2023-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976639180014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976639180014069766391800146976639180014

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

Regulatory Flags#

DUNS number
699438155
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976639180007StarsleepRotary nursing care bed, Orin2023-09-28

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
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
00850045714048Soteria Bed BarrierTrinity Guardion, Inc.QTV2023-03-13