FDA.reportPublic FDA data

Showering and changing table 3000

Primary DI
05708590357461
Brand
Showering and changing table 3000
Company
Pressalit A/S
Model
R8435313
Catalog number
R8435313021
Device description
Showering and changing table 3000, fixed height, 1300 mm, with safety rail and water collection tray, lead grey
Published
2020-06-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
05708590357461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708590357461057085903574615708590357461

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.

Contacts#

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

Regulatory Flags#

DUNS number
305656662
Device count
1
DM exempt
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708590357478Showering and changing table 3000R8435318R84353180212020-06-08
05708590357539Showering and changing table 3000R8592318R85923180212020-06-08
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

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