FDA.reportPublic FDA data

K-3oem EZ-ZONE

Primary DI
00817012027426
Brand
K-3oem EZ-ZONE
Company
KAP MEDICAL
Model
K-3oem-UK-B42
Catalog number
K-3oem-UK-B42
Device description
Pulsation, True Low Air Loss 10" High 42" Wide Mattress, Bariatric UK System
Published
2020-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00817012027426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012027426008170120274268170120274260817012027426

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00817012031683K-4 D3XK-4-NS-AVL-MS-NK-4-NS-AVL-MS-N2025-06-06
00817012031669K-3 AIRE-ZONEK-3-W2.0-BB-U-MSK-3-W2.0-BB-U-MS2025-04-04
00817012031676K-Zoem EZ-TURNK-Zoem-UK-AP-MSK-Zoem-UK-AP-MS2025-04-04
00817012031652K-2oemFAMSK-2oem-AU-CONV-X-MSK-2oem-AU-CONV-X-MS2025-01-10
00817012031621K-6 AIRE-TURN ASSISTK-6oemANK-6oemAN2024-11-22

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