FDA.reportPublic FDA data

K-0 SGS SKINGUARD

Primary DI
00817012022322
Brand
K-0 SGS SKINGUARD
Company
KAP MEDICAL
Model
U-K-0 SGSB84
Catalog number
U-K-0 SGSB84
Device description
"SkinGuard microclimate control system, 84"" x 36"""
Published
2019-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00817012022322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817012022322008170120223228170120223220817012022322

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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00670482001026oneNEST MUmano Medical IncIOQ2026-04-24
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00887761007543pro+HILL-ROM, INC.IOQ2026-04-20
00887761976863pro+HILL-ROM, INC.IOQ2026-04-20
00887761976887pro+HILL-ROM, INC.IOQ2026-04-20
00887761007666pro+HILL-ROM, INC.IOQ2026-03-27
00887761007697pro+HILL-ROM, INC.IOQ2026-03-27
00887761007703pro+HILL-ROM, INC.IOQ2026-03-27
00887761007505pro+HILL-ROM, INC.IOQ2026-03-25
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00887761007550pro+HILL-ROM, INC.IOQ2026-03-25
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00887761007581pro+HILL-ROM, INC.IOQ2026-03-25
00887761007598pro+HILL-ROM, INC.IOQ2026-03-25
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00887761007628pro+HILL-ROM, INC.IOQ2026-03-25
00887761007635pro+HILL-ROM, INC.IOQ2026-03-25
00887761007642pro+HILL-ROM, INC.IOQ2026-03-25
00887761007659pro+HILL-ROM, INC.IOQ2026-03-25
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