FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Raz
DI: 00062875800444
·
Model: Raze
·
Raz Design Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Raz
- Primary DI
- 00062875800444
- Version / Model
- Raze
- Catalog Number
- Z444
- Company Name
- Raz Design Inc
- Labeler DUNS
- 206941366
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-11
- Public Version
- 3
- Public Version Date
- 2025-07-10
- Public Version Status
- Update
- Public Device Record Key
- da2ba8d7-540f-4c68-a6db-10b636a3b241
- Distribution End Date
- 2025-05-28
Device Description
The Raze is a versatile stationary shower commode chair that can be configured as a raised toilet seat, a transfer tub seat or as a shower bench. Its tool less / adjustable design makes it portable and easy to adapt for different bathroom environments. Note: This DI was entered in error due to a typo. Correct DI is 00628758004448
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
- 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 |
|---|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | Physical Medicine | 890.3100 | 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 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., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00062875800444 | GS1 |
Customer Contacts
- Phone
- 4167515678
- [email protected]
- Phone
- 4167515678
- [email protected]