FDA.reportPublic FDA data

SleepSafe

Primary DI
10860000213735
Brand
SleepSafe
Company
SLEEPSAFE BEDS, LLC
Model
Manual Hi-Lo
Published
2019-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000213735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086000021373510860000213735

GMDN Terms#

Term, Definition table
TermDefinition
Manual hospital bedA mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.

Regulatory Flags#

DUNS number
613022636
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860000213711SleepSafeFixed2019-07-22
10860000213728SleepSafeManual Articulation2019-07-22
10860000213742SleepSafeManual Hi-Lo Combo2019-07-22
10860000213759SleepSafeManual Electric Combo2019-07-22
10860000213766SleepSafeElectric Articulation2019-07-22
10860000213773SleepSafeElectric Hi-Lo Combo2019-07-22
10860000213780SleepSafeFreight Part(s)2019-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34895262521519HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521471HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521488HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521495HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521501HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521518HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521525HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521532HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
06975575170189YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170196YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170202YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
05060631840548SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-21
05060631840005SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840012VoyagerSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840029Voyager CompactSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840500SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840517SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30