FDA UDI
In Commercial Distribution
🇺🇸 United States
Axiom
DI: 00840363305721
·
Model: Softgoods
·
KI MOBILITY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axiom
- Primary DI
- 00840363305721
- Version / Model
- Softgoods
- Catalog Number
- 14859
- Company Name
- KI MOBILITY, LLC
- Labeler DUNS
- 609305656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-02
- Public Version
- 1
- Public Version Date
- 2024-01-10
- Public Version Status
- New
- Public Device Record Key
- 81c7d0e6-4571-4411-8d99-6e783ff8754d
Device Description
Dynaform Anterior Trunk Support: Slim Cut, Dynamic, Large
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KNO | ACCESSORIES, WHEELCHAIR | Physical Medicine | 890.3910 | 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 | 00840363305721 | GS1 |
Customer Contacts
- Phone
- +1(800)981-1540
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |