FDA.reportPublic FDA data

CHS

Primary DI
00628725096667
Brand
CHS
Company
Stadco PolyProducts Inc
Model
SB1005-G
Catalog number
SB1005-G
Device description
SITZ BATH GOLD WITH TUBING
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
50628725096662PrimaryGS10
00628725096667Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5062872509666250628725096662
00628725096667006287250966676287250966670628725096667

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).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
247651813
Device count
10
DM exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628725096339CHSEM1001-1EM1001-12023-07-07
00628725096414CHSEM1001EM10012023-07-06
00628725096438CHSEM1001-GREYEM1001-GREY2023-07-06
00628725096445CHSEM1001-MEM1001-M2023-07-06
00628725096452CHSEM1002EM10022023-07-06
00628725096469CHSEM1002-MEM1002-M2023-07-06
00628725096476CHSEM1002-TURQEM1002-TURQ2023-07-06
00628725096483CHSEM1003EM10032023-07-06
00628725096490CHSRAB1009RAB10092023-07-06
00628725096506CHSRB1008RB10082023-07-06
00628725096513CHSS2002S20022023-07-06
00628725096520CHSS2007S20072023-07-06
00628725096537CHSS2008S20082023-07-06
00628725096544CHSS2009S20092023-07-06
00628725096551CHSS2011-CLS2011-CL2023-07-06
00628725096568CHSS2011-MS2011-M2023-07-06
00628725096575CHSS2012S20122023-07-06
00628725096582CHSS2012-GS2012-G2023-07-06
00628725096599CHSS2012-MS2012-M2023-07-06
00628725096605CHSS3000 PPS3000 PP2023-07-06

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