FDA.report

Immedia

Primary DI
05708012145201
Brand
Immedia
Company
Etac Immedia A/S
Model
OneWayGlide Non-Slip
Catalog number
IM37/8
Published
2022-10-31
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

Related Records

Product Codes

CodeName
IKXAID, TRANSFER

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708012145201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708012145201057080121452015708012145201

GMDN Terms

TermDefinition
Wheelchair seat cushionA padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
305519845
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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 DIBrandModelCatalogPublished
05708012000258ImmediaMultiGlide SG vertical XLIM00120/12022-10-31
05708012000265ImmediaMultiGlide vertical XXXL w/handlesIM160DR2022-10-31
05708012000272ImmediaMultiGlide vertical XXL w/handlesIM130DR2022-10-31
05708012000302ImmediaMultiGlide vertical XXLIM1302022-10-31
05708012000319ImmediaMultiGlide vertical MIM1082022-10-31
05708012000326ImmediaMultiGlide vertical XSIM103/12022-10-31
05708012001095ImmediaSatinSheet 2Direction CornerIM4107S2022-10-31
05708012001118ImmediaSatinSheet 2Direction FitIM4112S2022-10-31
05708012001125ImmediaSatinSheet 2Direction midiIM4113S2022-10-31
05708012001163ImmediaSatinSheet 2Direction PillowCaseIM4117S2022-10-31
05708012001170ImmediaSatinSheet DrawSheet midiIM4118S2022-10-31
05708012001385ImmediaSatinSheet 4Direction Fit midi setIM4203S2022-10-31
05708012001408Immedia4WayGlide LPL w/3x lock setIM43002022-10-31
05708012001415Immedia4WayGlide - mini setIM43012022-10-31
05708012001439ImmediaGlideCushion S setIM43032022-10-31
05708012001453ImmediaTransferMattress - wide setIM43052022-10-31
05708012001507ImmediaPediTurn HardIM997002022-10-31
05708012001668ImmediaMultiGlide vertical LIM1202022-10-31
05708012001781ImmediaMiniBoard LIM80150542022-10-31
05708012001798ImmediaSmartMove w/4 handlesIM4262022-10-31

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