FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenx
DI: 05056235200208
·
Model: JM01-06
·
JENX LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jenx
- Primary DI
- 05056235200208
- Version / Model
- JM01-06
- Company Name
- JENX LIMITED
- Labeler DUNS
- 291659639
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-29
- Public Version
- 1
- Public Version Date
- 2023-10-09
- Public Version Status
- New
- Public Device Record Key
- 39786ad2-4173-4a67-9224-0ff24c89c931
Device Description
Y Base Black
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 |
|---|---|---|---|---|
| 63867 | Assistive ergonomic chair/table base | A manually-operated, non-powered device intended to support an assistive ergonomic chair or table (not included) to facilitate mobility and/or maintain the seated position of a disabled (often paediatric) patient; it is intended to be operated by a healthcare provider/carer. It typically consists of a framework on legs or wheels with a chair/seat/table mount, a handle, and brake; it may include a non-powered or hydraulically-assisted lifting or tilting mechanism. It is not a wheelchair component. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056235200208 | GS1 |