FDA.reportPublic FDA data

SHOWER & DISINFECTION PANEL

Primary DI
05055982707916
Brand
SHOWER & DISINFECTION PANEL
Company
Arjohuntleigh AB
Model
BCA1214-04
Catalog number
BCA1214-04
Device description
SHOWER & DISINFECTION PANEL, WHITE, US, with FLUSH TANK
Published
2024-05-22
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
05055982707916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982707916050559827079165055982707916

GMDN Terms#

Term, Definition table
TermDefinition
Shower unitAn electrically-powered device intended to deliver a pressurized stream of water for cleaning/washing patients or devices. It may include a function to mix a disinfectant with water prior to delivery. It may also include additional devices for seating a patient and/or collection of discharged water (e.g., sink).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800) 323-1245us.info@arjo.com

Regulatory Flags#

DUNS number
355804758
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055982794619Maxi AirMAS000001-USMAS000001-US2022-07-30
15059441537295AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
15059441537301AIRPALAP-034SPNB AP-034SPNB 2026-03-23
15059441537318AIRPALAP-034SPNBSHAP-034SPNBSH2026-03-23
15059441537325AIRPALAP-039SPNB AP-039SPNB 2026-03-23
15059441537332AIRPALAP-039SPNBSH AP-039SPNBSH2026-03-23
15059441537349AIRPALAP-050SPNB AP-050SPNB 2026-03-23
05059441537298AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
05059441537304AIRPALAP-034SPNB AP-034SPNB 2026-03-23
05059441537311AIRPALAP-034SPNBSHAP-034SPNBSH2026-03-23
05059441537328AIRPALAP-039SPNB AP-039SPNB 2026-03-23
05059441537335AIRPALAP-039SPNBSH AP-039SPNBSH2026-03-23
05059441537342AIRPALAP-050SPNB AP-050SPNB 2026-03-23
05059441380450Arjo Loop Ambulatory SlingMLA5100-SMLA5100-S2026-03-09
05059441380467Arjo Loop Ambulatory SlingMLA5100-MMLA5100-M2026-03-09
05059441380474Arjo Loop Ambulatory SlingMLA5100-LMLA5100-L2026-03-09
05059441380481Arjo Loop Ambulatory SlingMLA5100-XLMLA5100-XL2026-03-09
05059441461654TherarestTRMRLNB35579TEGTRMRLNB35579TEG2026-02-10
05059441268482TherarestTRMRLNB34078CHG2022-07-30
05059441268499TherarestTVMRLNB35080CHG2022-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04895262521051HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521068HOMLANDHongKong 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