DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383989822
• Version / Model: 146-RTLPC23234
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 1
• Public Version Date: 2019-07-01
• Public Version Status: New
• Public Device Record Key: 9410c5f4-d380-403e-b03c-e0b5aec12594

Device Description

Personal CareAids to Daily Living Product Description: Sitz Bath,1EA,6/CS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTC	Bath, sitz, nonpowered	Physical Medicine	890.5125	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46293	Sitz bath kit, reusable	A 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., a rigid 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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822383989822	GS1