FDA.reportPublic FDA data

K-3oem EZ-ZONE

Primary DI
00817012024982
Brand
K-3oem EZ-ZONE
Company
KAP MEDICAL
Model
K-3oem-EU-FP-MS
Catalog number
K-3oem-EU-FP-MS
Device description
"Pulsation, True Low Air Loss 10"" High Foam Perimeter Mattress, Standard EU System"
Published
2020-06-04
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
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817012024982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012024982008170120249828170120249820817012024982

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
951-340-4360sales@kapmedical.com

Regulatory Flags#

DUNS number
135241342
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
00817012031881K-0 ECO-ZONEK-0-CONV-X-MSK-0-CONV-X-MS2026-05-26
00817012031898K-0 ECO-ZONEK-0-RTC-CONV-X-MSK-0-RTC-CONV-X-MS2026-05-26
00817012031850K-6 TURN-ZONEU-K-6-MSU-K-6-MS2026-01-16
00817012031812K-2oem ALT-AIRE+K-2oem-AU-X-MS-D-8K-2oem-AU-X-MS-D2025-10-10
00817012031829K-6oem AIRE-TURN ASSIST K-6oem-AU-X-MS-D-8K-6oem-AU-X-MS-D-82025-10-10
00817012031836K-4oem AIRE-FLOATK-4oem-EU-X-MS-D-8K-4oem-EU-X-MS-D-82025-10-10
00817012031843K-Zoem EZ-TURNK-Zoem-EU-X-MS-D-8K-Zoem-EU-X-MS-D-82025-10-10
00817012031805K-4oem AIRE-FLOATMATRIX-ALALMS8MATRIX-ALALMS82025-10-01
00817012031775K-6oem AIRE-TURN ASSIST K-6oem-X-MS-D-8K-6oem-X-MS-D-82025-09-26
00817012031782K-6oem AIRE-TURN ASSIST K-6oem-EU-X-MS-D-8K-6oem-EU-X-MS-D-82025-09-26
00817012031799K-6oem AIRE-TURN ASSIST K-6oem-UK-X-MS-D-8K-6oem-UK-X-MS-D-82025-09-26
00817012031744K-2oem ALT-AIRE+K-2oem-X-MS-D-8K-2oem-X-MS-D-82025-09-19
00817012031751K-2oem ALT-AIRE+K-2oem-EU-X-MS-D-8K-2oem-EU-X-MS-D-82025-09-19
00817012031768K-2oem ALT-AIRE+K-2oem-UK-X-MS-D-8K-2oem-UK-X-MS-D-82025-09-19
00817012031720K-4oem AIRE-FLOATMATRIX-ALALMS8X84MATRIX-ALALMS8X842025-09-05
00817012031737K-6 TURN-ZONEK-6-MS-84-DK-6-MS-84-D2025-09-04
00817012022179K-Z ZM ZMattQRCLRTB80SYSXMSQRCLRTB80SYSXMS2025-06-27
00817012031690K-4 D3XK-4-CMS-MS-8-DK-4-CMS-MS-8-D2025-06-13
00817012031706K-4 D3XK-4-CMS-B48-84-DK-4-CMS-B48-84-D2025-06-13
00817012031713K-4 D3XK-4-CMS-MS-84-8-DK-4-CMS-MS-84-8-D2025-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654562703Multicare XL I N E T spol. s r.o.IOQ2026-01-07
08592654550441MulticareL I N E T spol. s r.o.IOQ2025-12-22
08592654510407MulticareL I N E T spol. s r.o.IOQ2025-05-26
00817012031669K-3 AIRE-ZONEKAP MEDICALIOQ2025-04-04
M368LS900361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900421LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900481LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT361LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT421LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M368LS900MAT481LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
M369LS900P1LUMEXGF HEALTH PRODUCTS, INC.IOQ2025-03-01
00887761007710Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007727Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007734Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007741Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007758Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
00887761007765Centrella™ SurfaceHILL-ROM, INC.IOQ2024-11-27
08592654466933Multicare XL I N E T spol. s r.o.IOQ2024-10-23
00887761966819Centrella™ SurfaceHILL-ROM, INC.IOQ2024-09-20
10670482000774oneNEST MUmano Medical IncIOQ2024-06-21
06977071938102MeicenGuangdong Meicen Medical Equipment Co., Ltd.IOQ2024-06-21
04719873696901NACARILEX MEDICAL, INC.IOQ2024-06-20
14719873696915NACARILEX MEDICAL, INC.IOQ2024-06-20
04719873696925NACARILEX MEDICAL, INC.IOQ2024-06-20
14719873696939NACARILEX MEDICAL, INC.IOQ2024-06-20
00817012031485K-3oem EZ-AIREKAP MEDICALIOQ2024-06-14
10670482000781oneNEST MUmano Medical IncIOQ2024-06-07
10670482000798oneNEST M Control unit Umano Medical IncIOQ2024-06-07
10670482000804oneNEST M Control unitUmano Medical IncIOQ2024-06-07
00887761967182Progressa+ surfaceHill-Rom de México, S. de R.L. de C.V.IOQ2024-05-31