FDA.reportPublic FDA data

Sitz Bath

Primary DI
00810180844857
Brand
Sitz Bath
Company
Dynarex Corporation
Model
4228
Device description
Sitz Bath with Attachment and instructions 2.1qt. mauve
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00616784422831PrimaryGS10
00810180844857Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784422831006167844228316167844228310616784422831
00810180844857008101808448578101808448570810180844857

GMDN Terms#

Term, Definition table
TermDefinition
Sitz bath kit, single-useA collection of devices and supplies used for the administration of a limited bath performed by immersing only the hips, buttocks, and the perineal region of the patient into water or a water solution (i.e., a sitz bath). It typically consists of a basin (e.g., an inflatable plastic basin), an irrigation set with a bag, tubing, clamps and towels; some kits may include substances to add to the water (e.g., salts or herbs). This device is used with a sitz bath to maintain patient hygiene and for external hydrotherapy to alleviate pain and discomfort caused by haemorrhoids, uterine cramps, labour, and/or other diseases of the pelvic, abdominal and perineal area. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

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Primary DI, Brand, Company table
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07392532279416DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
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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
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07350016061612COMFORTLINE II, BATHTUB,40 MM DRAIN, TMV3Tr Equipment ABKTC2023-12-12