FDA.reportPublic FDA data

SKIN IQ

Primary DI
05055982783064
Brand
SKIN IQ
Company
Arjohuntleigh AB
Model
SIQCOST04UN
Device description
Skin IQ Microclimate Manager - Mattress Coverlet Only, 4 Pack
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
05055982783064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982783064050559827830645055982783064

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-air whole-body heating/cooling system pad, single-use, non-sterileA non-sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole-body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
355804758
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
05059441537298AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
05059441537304AIRPALAP-034SPNB AP-034SPNB 2026-03-23
05059441537311AIRPALAP-034SPNBSHAP-034SPNBSH2026-03-23
05059441537328AIRPALAP-039SPNB AP-039SPNB 2026-03-23
05059441537335AIRPALAP-039SPNBSH AP-039SPNBSH2026-03-23
05059441537342AIRPALAP-050SPNB AP-050SPNB 2026-03-23
05059441380450Arjo Loop Ambulatory SlingMLA5100-SMLA5100-S2026-03-09
05059441380467Arjo Loop Ambulatory SlingMLA5100-MMLA5100-M2026-03-09
05059441380474Arjo Loop Ambulatory SlingMLA5100-LMLA5100-L2026-03-09
05059441380481Arjo Loop Ambulatory SlingMLA5100-XLMLA5100-XL2026-03-09
05059441461654TherarestTRMRLNB35579TEGTRMRLNB35579TEG2026-02-10
05056097349510SARA FLEXTSS.500WTSS.500W2022-09-03
05056097364049SARA FLEXTSS.503WTSS.503W2022-09-03
05056097369921SARA FLEXTSS.501WTSS.501W2022-09-03
05056097369938SARA FLEXTSS.502WTSS.502W2022-09-03
05059441536024AtmosAir Velaris633042US633042US2026-01-15
05059441536031AtmosAir Velaris633043US633043US2026-01-15
05059441536048AtmosAir Velaris633044US633044US2026-01-15
05059441536055AtmosAir Velaris633045US633045US2026-01-15
05059441536062AtmosAir Velaris633046US633046US2026-01-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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