FDA UDI
In Commercial Distribution
🇺🇸 United States
Carex Health Brands
DI: 00815067012558
·
Model: FGB341GB THD
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Carex Health Brands
- Primary DI
- 00815067012558
- Version / Model
- FGB341GB THD
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-20
- Public Version
- 1
- Public Version Date
- 2024-02-28
- Public Version Status
- New
- Public Device Record Key
- 4288223d-5b88-4197-8a7e-1d54e3f1b8a3
Device Description
3-IN-1 COMMODE THD 1010590235
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 |
|---|---|---|---|---|
| ILS | Adaptor, Hygiene | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40539 | Commode, manual | A non-active, manually-operated transportable device in the form of a chair with a built-in receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., during shower). Also known as a sanichair, it may include hydraulically-assisted seat height adjustment, and may or may not be supplied with wheels (castors). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30815067012559 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 00815067012558 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]