FDA.reportPublic FDA data

THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEM

Primary DI
00850520008167
Brand
THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEM
Company
KREG MEDICAL INC.
Model
ASM100203
Device description
Hospital Bed Surface
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
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850520008167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850520008167008505200081678505200081670850520008167

GMDN Terms#

Term, Definition table
TermDefinition
Low-air-loss bedA mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.

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
00850520008143CATALYST NON-EXPANDABLE BEDASM1001132018-09-21
00850520008150THE KREG INTEGRATED CLRT MATTRESS SYSTEMASM1002022018-09-21
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
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00817012031911K-4 D3XKAP MEDICALFNM2026-05-29
04719893356434WellellWellell Inc.FNM2026-04-20
H93338036Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338042Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338436Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H93338442Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
H9336200Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-04-13
04719893356922WellellWellell Inc.FNM2026-03-20
H933PR13051Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2025-12-01
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00810055884261ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884278ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884285ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884292ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884308ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00023601033093CAREX HEALTH BRANDSDrive Devilbiss HealthcareFNM2024-06-13
H93365077Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-04-16
H93364565Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2024-02-14
00190885000049MatrixMidtown Investments, LLCFNM2023-01-28
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00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28