FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DRIVEMEDICAL
DI: 50050428804693
·
Model: 741742
·
Drive Devilbiss Healthcare
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- DRIVEMEDICAL
- Primary DI
- 50050428804693
- Version / Model
- 741742
- Company Name
- Drive Devilbiss Healthcare
- Labeler DUNS
- 867673159
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-21
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 36b8bf8d-cebf-4357-9876-d54b52d81c43
- Distribution End Date
- 2024-01-29
Device Description
Personal CareAids to Daily Living Product Description: Sitz Bath, 6/cs, RTL
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 |
|---|---|---|---|---|---|---|
| Package | 00050428804698 | GS1 | 6 | Not in Commercial Distribution | 2024-01-29 | |
| Primary | 50050428804693 | GS1 |