FDA.report

SKIN IQ 365

Primary DI
05055982783217
Brand
SKIN IQ 365
Company
Arjohuntleigh AB
Model
SIQCORUS1UN
Device description
SKIN IQ 365, COVERLET ONLY
Published
2016-09-29
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
false

Related Records

Product Codes

CodeName
IOQBED, FLOTATION THERAPY, POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055982783217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055982783217050559827832175055982783217

GMDN Terms

TermDefinition
Circulating-air whole-body heating/cooling system pad, reusableAn 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 reusable device.

Sterilization Methods

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

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