FDA.reportPublic FDA data

PLUS

Primary DI
05708590368368
Brand
PLUS
Company
Pressalit A/S
Model
R371385
Catalog number
R371385108
Device description
PLUS support arm, 850 mm, dark blue. Height adjustable, left hand operated, for retro-fitting
Published
2020-06-08
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
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708590368368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708590368368057085903683685708590368368

GMDN Terms#

Term, Definition table
TermDefinition
Toilet hand railA device of various bar-shaped designs intended to provide a person with a disability a supportive hand-hold when lowering or raising their body to or from the toilet. It may be designed to be wall-mounted or affixed to the toilet.

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
05708590357461Showering and changing table 3000R8435313R84353130212020-06-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818323020014ViveVIVE HEALTH LLCILS2026-07-16
00810226441002ViveVIVE HEALTH LLCILS2026-07-08
00023601023186CarexDrive Devilbiss HealthcareILS2026-04-29
14895262521362HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
14895262521829SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521048HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521390HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521574HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
24895262521727SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521304HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521670HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
34895262521779SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521578HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521677HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521721SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
44895262521776SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521544HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
54895262521551HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521159HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
74895262521166HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-22
00194346699421EquateWAL-MART STORES, INC.ILS2026-04-17
04895262521013HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521020HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521037HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521044HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-13
00023601023827CarexDrive Devilbiss HealthcareILS2026-04-07
00023601658500CarexDrive Devilbiss HealthcareILS2026-01-12
00023601088215CarexDrive Devilbiss HealthcareILS2025-10-16
00023601088208CarexDrive Devilbiss HealthcareILS2025-06-25
00810178882403ViveVIVE HEALTH LLCILS2025-05-20