FDA.reportPublic FDA data

CATALYST NON-EXPANDABLE BED

Primary DI
00850520008143
Brand
CATALYST NON-EXPANDABLE BED
Company
KREG MEDICAL INC.
Model
ASM100113
Device description
Hospital Bed with Standing Frame
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850520008143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850520008143008505200081438505200081430850520008143

GMDN Terms#

Term, Definition table
TermDefinition
Bariatric bedA mains electricity (AC-powered) bed specifically designed as a bed to accommodate a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys, i.e., 500 kg total, including the weight of the mattress and other accessories. Features like size, shape, and patient comfort (both physical and mental) will be taken into consideration by the design. This device is electrically-operated to assist the user/attending staff to adjust the functions and positions of the bed. It will typically include adjustable height, back rest, knee-break, removable head and foot ends and possibly an integrated weighing facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 760-5734kmiudiInfo@kreg.us

Regulatory Flags#

DUNS number
079220324
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850520008280AP MAX MATTRESS SYSTEMASM2001042023-10-16
00850520008013OXYGEN TANK HOLDERASM1002172020-06-12
00850520008099EZ WIDER, FOOT WIDTH EXTENSION - RHASM2001142020-06-12
00850520008112EZ WIDER, FOOT WIDTH EXTENSION - LHASM2001152020-06-12
00850520008129EZ WIDER, FOOT LENGTH EXTENSIONASM1001062020-06-12
00850520008006SINGLE ARM TRAPEZE ASSEMBLYASM1001052018-09-21
00850520008020CATALYST BARIATRIC BEDASM1001122018-09-21
00850520008037THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM2001002018-09-21
00850520008044STAGE IV, LOW AIR LOSS, L/PASM2001112018-09-21
00850520008051EZ WIDER BARIATRIC BEDASM1001292018-09-21
00850520008068EZ WIDER BARIATRIC BEDASM1001002018-09-21
00850520008075EZ WIDER BARIATRIC BEDASM1001302018-09-21
00850520008082EZ WIDER BARIATRIC BEDASM1001042018-09-21
00850520008150THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM1002022018-09-21
00850520008167THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEMASM1002032018-09-21
00850520008174VISCO MEMORY FOAM MATTRESS ASSEMBLYASM1001162018-09-21
00850520008181COMPOSURE MATTRESS ASSEMBLYASM1002042018-09-21
00850520008198KREG AIR, STAGE IV, LOW AIR LOSS, L/P, EZ WIDERASM1001032018-09-21
00850520008204COVERLET WITH ZIPPERASM1001172018-09-21
00850520008211COVERLET WITH ZIPPERASM1001182018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977918410143SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNL2026-06-08
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