FDA.reportPublic FDA data

Sitz Bath

Primary DI
00616784422831
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
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.

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
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00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
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00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
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00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
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