FDA.reportPublic FDA data

Sterex

Primary DI
06977918410020
Brand
Sterex
Company
JIANGMEN ELITE MEDICAL EQUIPMENT LTD
Model
HOFF750
Published
2024-11-18
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNLBed, Ac-Powered Adjustable Hospital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNLBed, Ac-Powered Adjustable HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977918410020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977918410020069779184100206977918410020

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric hospital bedA mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
456839550
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
06977918410150SterexHOFF750SAPIR2026-06-10
06977918410143SterexHOFF650SAPIR2026-06-08
00369771005615GeriGentleEQ37-GSB36802026-02-09
00369771005684GeriGentleEQ37-GBQR2026-02-09
00369771005691GeriGentleEQ37-GBAB 2026-02-09
00369771005707GeriGentleEQ37-GBSR2026-02-09
06977918410136SterexHOFFSHR2025-06-17
06977918410129SterexHOFF6502025-03-13
06977918410099AireMedAIR-10ST2024-12-03
06977918410105AireMedAIR-RHCB2024-12-03
06977918410112AireMedAIR-RHCI2024-12-03
06977918410013SterexHOFF5002024-11-18
06977918410037SterexSTR500LB2024-11-18
06977918410044SterexSTR500PB2024-11-18
06977918410051SterexSTR600PB2024-11-18
06977918410068SterexSTR600LB2024-11-18
06977918410075SterexSTS5002024-11-18
06977918410082SterexSTS6002024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972077025191CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500071SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500088DALTONXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500095CostcareXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500415SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500422SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500439SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500446SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500453SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500460SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500477SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500484SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500491SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500507SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500514SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500521SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06975084500538SPECIALTYXIAMEN ATLANTIS MFC CO.,LTDFNL2026-09-19
06979878770312CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770329CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770336CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770343CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770350CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
06979878770367CostcareFujian Pacific Medical Manufacturing Co.,LtdFNL2026-08-21
008408281968570103,SCC,10',RAULAND LABELED,UL,PVC-FREECURBELL MEDICAL PRODUCTS, INC.FNL2026-07-23
08592654620359Eleganza 5L I N E T spol. s r.o.FNL2026-07-17
08592654621752Eleganza 5L I N E T spol. s r.o.FNL2026-07-17
04719876190055TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190277TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190574TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08
04719876190581TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNL2026-07-08