FDA.reportPublic FDA data

Showering and changing table 2000

Primary DI
05708590355849
Brand
Showering and changing table 2000
Company
Pressalit A/S
Model
R8592418
Catalog number
R8592418000
Device description
Showering and changing table 2000, coated canvas, 120V, electrically height adjustable with wired remote control, 1800 mm, with safety rail and water collection tray, white
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
INQTable, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708590355849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708590355849057085903558495708590355849

GMDN Terms#

Term, Definition table
TermDefinition
Bathing/changing table, stationaryA raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off), either mounted on a fixed frame with legs or wall-mounted (may be height-adjustable), designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff) or shower. The device is used primarily for a patient with a disability incapable of supporting themself in an upright position. It is designed to be stationary and is used in one location.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4587888788pressalit@pressalit.com

Regulatory Flags#

DUNS number
305656662
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708590394923MCT 3R9662714R96627140002025-10-22
05708590389844MSCT 4R95047R95047170002024-11-05
05708590389851MSCT 4R95047R95047210002024-11-05
05708590389868MCT 5R95027R95027170002024-11-05
05708590389875MCT 5R95027R95027190002024-11-05
05708590389882MCT 5R95027R95027210002024-11-05
05708590389981MCT3R9662717R96627170002023-09-11
05708590389998MCT3R9662719R96627190002023-09-11
05708590390000MCT3R9662721R96627210002023-09-11
05708590380988MATRIX M R482619R4826190002023-01-26
05708590381008MATRIX MR482819R4828190002023-01-26
05708590377711VALUER1620000R16200001122022-01-01
05708590377728VALUER1622000R16220001122022-01-01
05708590376585CT 5000R8455512R84555120002021-12-01
05708590372167SCT 2000R8425218R84252180002021-11-15
05708590372174SCT 2100R8425418R84254180002021-11-15
05708590376127SCT 2000R8591218R85912180002021-11-15
05708590376134SCT 2000R8591418R85914180002021-11-15
05708590374420PLUSR7834R78341122021-06-14
05708590374437PLUSR7835R78351122021-06-14

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Primary DI, Brand, Company table
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