FDA.reportPublic FDA data

Primo

Primary DI
05055982713412
Brand
Primo
Company
Arjohuntleigh AB
Model
AP31202US1000
Device description
Bath System - Primo Sys23 SB P220 Des
Published
2016-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ILJBath, hydro-massage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILJBath, Hydro-MassagePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055982713412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982713412050559827134125055982713412

GMDN Terms#

Term, Definition table
TermDefinition
Hydrotherapy bath/tankA bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
355804758
Device count
1
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
00199874983844Apollo CorpAPOLLO CORP.ILJ2025-11-17
05059441219576Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219583Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219590Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219606Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219613Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219620Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219637Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219644Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219651Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219668Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219675Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219682Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219699Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219705Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268277Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268291Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268307Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306108Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306115Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306122Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310174Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310181Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310198Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310204Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310211Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310228Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310235Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310242Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310259Symbliss BathArjohuntleigh ABILJ2024-09-25