FDA.reportPublic FDA data

MEDACURE

Primary DI
00853223008199
Brand
MEDACURE
Company
MEDACURE INC.
Model
SLB48-X
Device description
AMERICAN SPIRIT
Published
2019-02-15
Public version status
New
Distribution status
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
00853223008199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853223008199008532230081998532230081990853223008199

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
079352467
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
00853223008397MEDACURECB6502020-10-01
00853223008403MEDACURECB10002020-10-01
00853223008014MEDACUREFS6602019-02-15
00853223008359MEDACUREWC26202020-10-02
00853223008366MEDACUREWC28202020-10-02
00853223008373MEDACUREWC30202020-10-02
00853223008380MEDACUREGC5002020-10-01
00853223008410MEDACURERB5002020-10-01
00853223008342MEDACUREOS200-C2019-10-25
00853223008328MEDACUREULB7/302019-10-04
00853223008335MEDACUREULB48-X-7/302019-10-04
00853223008304MEDACUREPNP362019-09-27
00853223008311MEDACUREPNP36-RR2019-09-27
00853223008298MEDACUREBP3002019-09-12
00853223008021MEDACUREAL182019-08-16
00853223008038MEDACUREAL202019-08-16
00853223008045MEDACUREAL222019-08-16
00853223008052MEDACUREAL242019-08-16
00853223008007MEDACURELRM362019-02-15
00853223008069MEDACUREULB3.92019-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654283455Eleganza 5L I N E T spol. s r.o.FNL2022-12-21
M676MC7WSTMLB0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNL2022-11-08
10190676005557POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676006547POSEYPOSEY PRODUCTS, LLCFNL2022-10-06
10190676005588POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
10190676005601POSEYPOSEY PRODUCTS, LLCFNL2022-10-04
07613327584745Sidekick SpraySTRYKER CORPORATIONFNL2022-02-28
10080196313877MedlineMEDLINE INDUSTRIES, INC.FNL2020-11-12
M368GS4054DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-06
M368GS3648B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842B1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DNS1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
M368GS4842DW1GendronGF HEALTH PRODUCTS, INC.FNL2020-11-05
07613327541243ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541250ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541267ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541274ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541281ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541298ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541304ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541328ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541335ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541342ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541359ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541366ProCuitySTRYKER CORPORATIONFNL2020-10-05
07613327541373ProCuitySTRYKER CORPORATIONFNL2020-10-05
08592654185421Eleganza 3L I N E T spol. s r.o.FNL2018-10-29
08592654186190Eleganza 3L I N E T spol. s r.o.FNL2018-09-18
08592654114766Eleganza 3L I N E T spol. s r.o.FNL2018-04-09
08592654134481Eleganza 5L I N E T spol. s r.o.FNL2018-04-09