FDA UDI
In Commercial Distribution
🇺🇸 United States
CHS
DI: 50628725096679
·
Model: SB1005-M
·
Canadian Hospital Specialties Limited
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- CHS
- Primary DI
- 50628725096679
- Version / Model
- SB1005-M
- Catalog Number
- SB1005-M
- Company Name
- Canadian Hospital Specialties Limited
- Labeler DUNS
- 240992693
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 3
- Public Version Date
- 2023-09-13
- Public Version Status
- Update
- Public Device Record Key
- 2c167225-915b-4f5f-bd20-3a3557071cfd
Device Description
SITZ BATH MAUVE WITH TUBING
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 33676 | Sitz bath, non-powered | A tub that is filled with heated water and intended for use in external hydrotherapy to relieve pain or pruritus and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. The patient immerses only the hips and buttocks, keeping the legs outside of the tub. It is typically used to maintain patient hygiene and to alleviate pain and discomfort caused by haemorrhoids, uterine cramps, labour, and/or other diseases of the pelvic, abdominal and perineal area (e.g., prostate, bladder, bowel, vaginal disorders). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00628725096674 | GS1 | ||||
| Primary | 50628725096679 | GS1 |
Customer Contacts
- Phone
- 9058259300
- [email protected]