FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenx
DI: 05056235200253
·
Model: LY01-03
·
JENX LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jenx
- Primary DI
- 05056235200253
- Version / Model
- LY01-03
- 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
- bc70eb76-a3c6-46fd-886b-0680989748f0
Device Description
Ly-On Green
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 |
|---|---|---|---|---|
| INW | Table, Mechanical | Physical Medicine | 890.3750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32266 | Massage table/couch, non-powered, non-portable | A manually-adjusted table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It consists of a non-foldable framework (non-portable) with a flat tabletop surface which may have a head section, headrest, a face hole (the patients face fits into this when lying prone), and/or armrest(s); positional adjustments of these components, including platform height, are made manually. It is typically known as a massage/therapy table, couch or bed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056235200253 | GS1 |