FDA.reportPublic FDA data

K-4 D3X

Primary DI
00817012031911
Brand
K-4 D3X
Company
KAP MEDICAL
Model
K-4-NS-BB-AVL
Catalog number
K-4-NS-BB-AVL
Device description
Alternating Pressure, Battery Backup, Auto Variable Length, Auto Set, Pulsation, Control Unit.
Published
2026-05-29
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
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
00817012031911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012031911008170120319118170120319110817012031911

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.

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
00817012031867K-6oem AIRE-TURN ASSISTK-6oem VersaAir Bari Alt-TurnK-6oem VersaAir Bari Alt-Turn2026-05-29
00817012031874K-2oem ALT-AIRE+K-2oem VersaAir Bari AltK-2oem VersaAir Bari Alt2026-05-29
00817012031904K-4 D3XK-4-NS-AVLK-4-NS-AVL2026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031874K-2oem ALT-AIRE+KAP MEDICALFNM2026-05-29
00817012031904K-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
00810055884230ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884247ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884254ProCair PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
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
00810055884315ProMatt PlusJOERNS HEALTHCARE, LLCFNM2024-12-16
00810055884322ProMatt 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
00190885000056MatrixMidtown Investments, LLCFNM2023-01-28
00190885000063MatrixMidtown Investments, LLCFNM2023-01-28
00190885000070MatrixMidtown Investments, LLCFNM2023-01-28
00190885000087MatrixMidtown Investments, LLCFNM2023-01-28
00190885000094MatrixMidtown Investments, LLCFNM2023-01-28
00190885000100MatrixMidtown Investments, LLCFNM2023-01-28