Sitz Bath

GUDID 00616784422824

Sitz Bath with Attachment and instructions 2.1qt. mauve

DYNAREX CORPORATION

Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use Sitz bath kit, single-use
Primary Device ID00616784422824
NIH Device Record Keya532e725-5ceb-4ab8-b7ec-51dac9bea6ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSitz Bath
Version Model Number4228
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count10
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100616784422824 [Unit of Use]
GS100616784422831 [Primary]

FDA Product Code

KTCBath, Sitz, Nonpowered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-09
Device Publish Date2021-09-01

Devices Manufactured by DYNAREX CORPORATION

08401173287854 - DynaCare Tampons,Super,Plastic Applicator 2024-04-17 Unscented, Free of Dyes & Perfumes
00860008059512 - IV Start Kit2024-04-10
00840117333215 - Instant Cold Pack, 4" x 5" 2024-04-08 For use whenever instant cold therapy is required
00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount2024-04-05
00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic2024-04-02 15" , Sterile
00840117333000 - XeroBurn Sterile Burn Dressing Blanket 2024-04-02 30" x 35"
00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70"2024-04-02 60"x 70"
00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95"2024-04-02 70" x 95"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.