FDA.reportPublic FDA data

sentida 03

Primary DI
08592654172155
Brand
sentida 03
Company
L I N E T spol. s r.o.
Model
1WIS156737231062
Device description
Basic electric home bed
Published
2018-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLIBed, Therapeutic, Ac-Powered, Adjustable Home-UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592654172155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592654172155085926541721558592654172155

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric home bedA mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.

Regulatory Flags#

DUNS number
644544504
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592654601235Sprint 2001ES200-1702026-05-11
08592654577462Eleganza 51GE512055-28372026-02-26
08592654578445Sprint 4001ES410-282026-02-26
08592654582992Eleganza 51GE512055-25972026-02-26
08592654544112OPTICARE1VSM-52026-01-07
08592654554524Sprint 1001ES105308-9742026-01-07
08592654562703Multicare X1MCX12050-9372026-01-07
08592654569405Eleganza 51GE512055-25952026-01-07
08592654550441Multicare1MC17350-23922025-12-22
08592654552889Eleganza 51GE512055-26772025-12-22
08592654556184Sprint 2001ES410-32025-12-22
08592654851067Ergozone 3000EZ3-SEN 2025-11-03
08592654851074Ergozone 3000EZ3-SENXL2025-11-03
08592654851081Ergozone 3000EZ3-SXXL 2025-11-03
08592654525883Sprint 2001ES400-52025-10-02
08592654542163Sprint 2001ES200-5212025-10-02
08592654542811Sprint 2001ES210-2102025-10-02
08592654542835Sprint 2001ES211-3092025-10-02
08592654851036Ergozone 3000EZ3-EMCX2025-06-24
08592654851043Ergozone 5000EZ5-EMCX2025-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344215454MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215461MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344215478MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-05-15
10197344176618MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-16
10197344176601MEDLINEMEDLINE INDUSTRIES, INC.LLI2026-03-13
00815027012628DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012635DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00815027012895DALTON FULL-ELECTRIC HOMECARE BEDDALTON MEDICAL CORPORATIONLLI2026-02-27
00841447116295Invacare® Bed Extender HeadspringINVACARE CORPORATIONLLI2025-12-05
05060631842580Cosyfit standard/Extra WideSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-21
05060631840036Siesta SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840166Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840173Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840180Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840364Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841101Cosyfit LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841194Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631841200Cosyfit Hi-Lo LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631842610Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843082Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843099Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843105Cosyfit Hi-Lo Profiling LongSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843129Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843136Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631843143Cosyfit Hi-Lo Profiling StandardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840104Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840111Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840128Cosyfit standardSAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840210Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12
05060631840227Cosyfit standard/Wide SAFESPACES (CORNHOLME) LIMITEDLLI2025-11-12