FDA.reportPublic FDA data

K-2oem ALT-AIRE+

Primary DI
00817012024463
Brand
K-2oem ALT-AIRE+
Company
KAP MEDICAL
Model
K-2oem-EU-MS
Catalog number
K-2oem-EU-MS
Device description
Alternating Pressure with On-Demand Low Air Loss 10" High Mattress, Standard EU System
Published
2020-06-03
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
00817012024463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012024463008170120244638170120244630817012024463

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
00817012031881K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
00817012031898K-0 ECO-ZONEKAP MEDICALFNM2026-05-26
04719893356922WellellWellell Inc.FNM2026-03-20
00860013391003ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391010ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391027ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391034ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391041ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00810178887040ViveVIVE HEALTH LLCFNM2026-03-06
00810178887057ViveVIVE HEALTH LLCFNM2026-03-06
H93392270Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-02-25
04719893356540WellellWellell Inc.FNM2026-02-11
00810178884193ViveVIVE HEALTH LLCFNM2026-02-02
00810178884483ViveVIVE HEALTH LLCFNM2026-01-30
05059441536024AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536031AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536048AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536055AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536062AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536079AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
08592654544112OPTICAREL I N E T spol. s r.o.FNM2026-01-07
00860014621895Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100412Thrive MedicalSupply Line MedicalFNM2025-12-26
00860015100429Thrive MedicalSupply Line MedicalFNM2025-12-26
04719873698608NACARILEX MEDICAL, INC.FNM2025-12-22
04719873698615NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698629NACARILEX MEDICAL, INC.FNM2025-12-22
14719873698636NACARILEX MEDICAL, INC.FNM2025-12-22
05061105057455Protekt VX 5000PROACTIVE MEDICAL PRODUCTS, LLCFNM2025-12-18
10193489148305MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12