FDA UDI
In Commercial Distribution
🇺🇸 United States
Carex
DI: 00023601088154
·
Model: FGE815C0 0000
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Carex
- Primary DI
- 00023601088154
- Version / Model
- FGE815C0 0000
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-17
- Public Version
- 1
- Public Version Date
- 2023-10-25
- Public Version Status
- New
- Public Device Record Key
- 51693ab4-fbbd-444d-9190-52d394ded05e
Device Description
Adj Toilet Safety frame
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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 31059 | Raised toilet seat | A non-powered seat designed to enable a person with a disability to sit on the toilet at an elevation above the conventional range for easier sitting and standing. It may be intended to attach to a standard toilet bowl or may be freestanding; it might also include armrests/bars to assist transfer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30023601088155 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00023601088154 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]