FDA UDI
In Commercial Distribution
🇺🇸 United States
Axiom
DI: 00840363365473
·
Model: PXPL
·
KI MOBILITY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Axiom
- Primary DI
- 00840363365473
- Version / Model
- PXPL
- Catalog Number
- PXPL1414
- Company Name
- KI MOBILITY, LLC
- Labeler DUNS
- 609305656
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-08
- Public Version
- 1
- Public Version Date
- 2024-01-16
- Public Version Status
- New
- Public Device Record Key
- c550019b-a9f0-45ac-81ca-eac4ae450ca6
Device Description
Pediatric Axiom Posterior Lateral Back 14X14
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 |
|---|---|---|---|---|
| KNN | COMPONENTS, WHEELCHAIR | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36254 | Wheelchair back rest | A padded support (typically vinyl covered) designed to attach to the back of a wheelchair. It typically replaces the wheelchair's sling upholstery and provides the wheelchair occupant with improved back support, posture, air circulation, and comfort. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840363365473 | GS1 |
Customer Contacts
- Phone
- +1(800)981-1540
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14X14 |