FDA.reportPublic FDA data

CHS

Primary DI
50628725096679
Brand
CHS
Company
Canadian Hospital Specialties Limited
Model
SB1005-M
Catalog number
SB1005-M
Device description
SITZ BATH MAUVE WITH TUBING
Published
2023-07-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTCBath, Sitz, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTCBath, Sitz, NonpoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50628725096679PrimaryGS10
00628725096674Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509667950628725096679
00628725096674006287250966746287250966740628725096674

GMDN Terms#

Term, Definition table
TermDefinition
Sitz bath, non-poweredA tub that is filled with heated water and intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. The patient immerses only the hips and buttocks, keeping the legs outside of the tub. It is typically used to maintain patient hygiene and to alleviate pain and discomfort caused by haemorrhoids, uterine cramps, labour, and/or other diseases of the pelvic, abdominal and perineal area (e.g., prostate, bladder, bowel, vaginal disorders).

Contacts#

Phone, Email table
PhoneEmail
9058259300regulatory.affairs@chsltd.com

Regulatory Flags#

DUNS number
240992693
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725095295MiniMuffs0402160403412025-04-11
00628725096940Nebulizer KitMS-6920S2024-02-23
00628725097336VixOne™ Nebulizer KitR-6415VR-6415V2023-06-16
00628725097688RespanR-7420SR-7420S2023-06-22
00628725097695Pediatric Nebulizer KitR-6920SR-6920S2023-06-15
00628725097732Adult Nebulizer KitMS-6420SMS-6420S2023-06-15
00628725098173VixOne™ Nebulizer KitR-6400R-64002023-06-15
00628725098203VixOne™ Nebulizer Kit R-6405SR-6405S2024-08-20
00628725098210VixOne™ Nebulizer KitR-6415SR-6415S2023-06-15
00628725098234VixOne™ Nebulizer KitR-6420SR-6420S2023-06-15
00628725098500VixOne™ Nebulizer KitR-8420SR-8420S2023-06-15
00628725095073MISI-Medical Imaging Solutions International100301T100301T2025-09-11
00628725095080MISI-Medical Imaging Solutions International1002011002012025-09-11
00628725095103MISI-Medical Imaging Solutions International2001012001012025-09-11
00628725095165MISI-Medical Imaging Solutions International2002012002012025-09-11
00628725095172MISI-Medical Imaging Solutions International200107D200107D2025-09-11
00628725095189MISI-Medical Imaging Solutions International200101i200101i2025-09-11
00628725095196MISI-Medical Imaging Solutions International200301A200301A2025-09-11
00628725095219MISI-Medical Imaging Solutions International200105A200105A2025-09-11
50628725095078MISI-Medical Imaging Solutions International100301T100301T2025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974021412637equate sitz bathWAL-MART STORES, INC.KTC2025-10-08
00661392012547LSL HEALTHCARELSL Industries, LLCKTC2025-05-16
10661392012544LSL HEALTHCARELSL Industries, LLCKTC2025-05-16
07392532279409DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07392532279416DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07350016060035Ecoline with mixer, 50 MM DRAIN, H=80 CMTr Equipment ABKTC2023-12-12
07350016060141TR1700 HI LO 230V incl. Mixer and showerTr Equipment ABKTC2023-12-12
07350016060189TR900CW HI LO 230V Cleaning & WhirlpoolTr Equipment ABKTC2023-12-12
07350016060196TR900CWA HI LO 230V Cleaning, Autofill & WhirlpoolTr Equipment ABKTC2023-12-12
07350016061414TR900C HI LO 230V Cleaning GETr Equipment ABKTC2023-12-12
07350016061421TR900C HI LO 110V Cleaning USTr Equipment ABKTC2023-12-12
07350016061438TR900CW HI LO 230V Cleaning & Whirlpool UK TMV3Tr Equipment ABKTC2023-12-12
07350016061445TR900CW HI LO 110V Cleaning & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061452TR900CW HI LO 230V Cleaning & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061469TR900A HI LO 230V Autofill Tr Equipment ABKTC2023-12-12
07350016061476TR900A HI LO 230V Autofill GETr Equipment ABKTC2023-12-12
07350016061483TR900A HI LO 230V Autofill UK TMV3Tr Equipment ABKTC2023-12-12
07350016061490TR900CA HI LO 230V Cleaning & Autofill Tr Equipment ABKTC2023-12-12
07350016061506TR900CA HI LO 230V Cleaning & Autofill GETr Equipment ABKTC2023-12-12
07350016061513TR900CA HI LO 110V Cleaning & Autofill USTr Equipment ABKTC2023-12-12
07350016061520TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061544TR900CW Fixed height 230VTr Equipment ABKTC2023-12-12
07350016061551TR900CW Fixed height 110V USTr Equipment ABKTC2023-12-12
07350016061568Hilo Bath TR 900 With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061575Hilo Bath TR 900 TMV3, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061582Hilo Bath TR 900 US With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061599Hilo Bath TR 900 A, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061605Hilo Bath TR 900 A TMV3, Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061612COMFORTLINE II, BATHTUB,40 MM DRAIN, TMV3Tr Equipment ABKTC2023-12-12