FDA UDI
In Commercial Distribution
🇺🇸 United States
203-5 SHOWER CHAIR
DI: 08055715702833
·
Model: 203-5 SHOWER CHAIR
·
ORMESA SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 203-5 SHOWER CHAIR
- Primary DI
- 08055715702833
- Version / Model
- 203-5 SHOWER CHAIR
- Company Name
- ORMESA SRL
- Labeler DUNS
- 432070019
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-31
- Public Version
- 1
- Public Version Date
- 2025-02-10
- Public Version Status
- New
- Public Device Record Key
- 61ef57d4-7653-4eac-bbb3-8196c2c89f63
Device Description
Push wheelchair intended for the personal hygiene operations of users with disabilities, , semi-self-sufficient or non-self-sufficient users with poor head and trunk control, tending to lose contact with the surface of the backrest and slide with the pelvis forward and who assistance assistance in the care and hygiene of their own person to maintain stability and safety for the user and the assistant.
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
- No
- 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 |
|---|---|---|---|---|
| INM | Chair, With Casters | Physical Medicine | 890.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34936 | Shower seat, non-powered | A non-powered device designed to be sat upon by a patient (adult or child) while washing in a shower, or other washing facility (e.g., bath). The patient is typically disabled, infirm, or is undergoing medical treatment and requires to be seated while bathing/showering. The device may be in the form of a portable chair/stool or a fixed seat (e.g., wall-mounted), and may include armrests, side supports, or grab handles; it is typically made of water-resistant or waterproof materials (e.g., plastic and metal-coated materials). It may be used in a hospital, institution, or home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08055715702833 | GS1 |