FDA.reportPublic FDA data

SCT 2000

Primary DI
05708590372167
Brand
SCT 2000
Company
Pressalit A/S
Model
R8425218
Catalog number
R8425218000
Device description
SCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted
Published
2021-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
INTPlinth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INTPlinthPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708590372167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708590372167057085903721675708590372167

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
05708590372174SCT 2100R8425418R84254180002021-11-15
05708590376127SCT 2000R8591218R85912180002021-11-15
05708590376134SCT 2000R8591418R85914180002021-11-15
05708590374420PLUSR7834R78341122021-06-14
05708590374437PLUSR7835R78351122021-06-14
05708590374444PLUSR7864R78641122021-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840314811042TABLE,TREATMENT,H-BRACE, BLACKHausmann Enterprises, LLCINT2024-10-07
00840314811059TABLE,TREATMENT,H-BRACEHausmann Enterprises, LLCINT2024-10-07
00840314811066TABLE,H-BRACE, Agate BlueHausmann Enterprises, LLCINT2024-10-07
00840314810823CUSTOM_HTT 4-legHausmann Enterprises, LLCINT2023-02-28
00840314810830CUSTOM_HTT 6-legHausmann Enterprises, LLCINT2023-02-28
00840314810847CUSTOM_HTT Space SaverHausmann Enterprises, LLCINT2023-02-28
00840314810854HTT, 4-leg, 24x72: L02-Folkstone Gray Laminate: V15-Slate Blue Upholstery: A03-SHausmann Enterprises, LLCINT2023-02-28
00840314810861HTT, 4-leg, 27x72: L03- Wild Cherry Laminate: V19-Navy Blue Pro-Form UpholsteryHausmann Enterprises, LLCINT2023-02-28
00840314810878HTT, 4-leg, 30x72: L02-Folkstone Gray Laminate: V19-Navy Blue Pro-Form UpholsterHausmann Enterprises, LLCINT2023-02-28
00840314810885HTT, 4-leg, Liftback, Shelf 72X30: L01-Natural Oak Laminate: V23-Black Pro-Form Hausmann Enterprises, LLCINT2023-02-28
00840314810892HTT, 4-leg, 78X30: L01-Natural Oak Laminate: V23-Black Pro-Form Upholstery: A09-Hausmann Enterprises, LLCINT2023-02-28
00840314810908HTT, 4-leg, 78X30: L01-Natural Oak Laminate: V23-Black Pro-Form Upholstery: A07-Hausmann Enterprises, LLCINT2023-02-28
00840314810915PT Table, 6-Legs,78X30X31: L01-Natural Oak Laminate: V20-Dove Gray Pro-Form UphoHausmann Enterprises, LLCINT2023-02-28
00840314810922PT Table, 6-Legs,78X30X31: L01-Natural Oak Laminate: V23-Black Pro-Form UpholsteHausmann Enterprises, LLCINT2023-02-28
008403148109396-Leg Split-Leg Table: L01-Natural Oak Laminate: L01-Black Pro-Form Upholstery: Hausmann Enterprises, LLCINT2023-02-28
00840314810946HTT Space Saver,52-72X24: L02-Folkstone Gray Laminate: V17-Gray UpholsteryHausmann Enterprises, LLCINT2023-02-28
00840314803009PT,TABLE,SPLIT LEG,HINGED DR CABINETHausmann Enterprises, LLCINT2022-08-31
00840314801654TABLE,TREATMENT,H-BRACE,72X24Hausmann Enterprises, LLCINT2022-08-16
00840314801661TABLE,TREATMENT,SHELF,72X24Hausmann Enterprises, LLCINT2022-08-16
00840314801678TABLE,TREATMENT,SHELF,CAB,72X24Hausmann Enterprises, LLCINT2022-08-16
00840314801685TABLE,TREATMENT,CABINET,72X24X31Hausmann Enterprises, LLCINT2022-08-16
00840314801692TABLE,TAPING,TWO-PERSON,74X34X36Hausmann Enterprises, LLCINT2022-08-16
00840314801708"TAPING BENCH TABLE,78x27x34"""Hausmann Enterprises, LLCINT2022-08-16
00840314801715TABLE,ORTHOPEDIC,CASTING,78X30X31Hausmann Enterprises, LLCINT2022-08-16
00840314801722"BARIATRIC,TABLE,78X34X30H"""Hausmann Enterprises, LLCINT2022-08-16
00840314801739TABLE,TREATMENT,FOLDING,72X24Hausmann Enterprises, LLCINT2022-08-16
00840314801746TABLE,MODALITY TREATMENT,78X30X31Hausmann Enterprises, LLCINT2022-08-16
00840314801753TABLE,DESK,W/MAT,GR/BL,FOLK,72X24Hausmann Enterprises, LLCINT2022-08-16
00840314801760TABLE,BARIATRIC,6 LEGS,OAK,78X30(LOW HT)Hausmann Enterprises, LLCINT2022-08-16
00840314801777TABLE,TAPING,H-BRACE,OAK,48X24(HT36)Hausmann Enterprises, LLCINT2022-08-16