Sitz Bath

GUDID 00616784422824

Sitz Bath with Attachment and instructions 2.1qt. mauve

DYNAREX CORPORATION

Sitz bath kit, single-use

• Primary Device ID: 00616784422824
• NIH Device Record Key: a532e725-5ceb-4ab8-b7ec-51dac9bea6ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sitz Bath
• Version Model Number: 4228
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784422824 [Unit of Use]
GS1	00616784422831 [Primary]

FDA Product Code

• KTC: Bath, Sitz, Nonpowered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-09
• Device Publish Date: 2021-09-01

Devices Manufactured by DYNAREX CORPORATION

• 00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO: 2025-08-27
• 00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704210 - IV Administration Sets, 10 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784704418 - IV Administration Set, 20 mL, Non-Toxic: 2025-08-11 Sterile-EO
• 00616784304113 - Dmecare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.
• 00616784304212 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 18"x 16". Weight Capacity: 300 LB
• 00616784304311 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 20" x 16". Weight Capacity: 300 LB
• 00616784304410 - DMECare Solutions Solid Seat Insert: 2025-07-17 Solid Seat Insert 22" x 18" Weight Capacity: 300 LB