FDA UDI
In Commercial Distribution
🇺🇸 United States
Jenx
DI: 05056235206286
·
Model: MB07-04
·
JENX LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Jenx
- Primary DI
- 05056235206286
- Version / Model
- MB07-04
- Company Name
- JENX LIMITED
- Labeler DUNS
- 291659639
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-06
- Public Version
- 2
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- ec412548-1de8-4565-a42d-8d1942b2a437
Device Description
Support Pads Medium With Strap Red
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
- Yes
- 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 |
|---|---|---|---|---|
| 13356 | Wheelchair/chair/stander occupant restraint/support | A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056235206286 | GS1 |