FDA UDI
In Commercial Distribution
🇺🇸 United States
WHEELCHAIR HEADREST
DI: 00606509900034
·
Model: WHEELCHAIR HEADREST
·
Pride Mobility Products Corp
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WHEELCHAIR HEADREST
- Primary DI
- 00606509900034
- Version / Model
- WHEELCHAIR HEADREST
- Catalog Number
- N/A
- Company Name
- Pride Mobility Products Corp
- Labeler DUNS
- 041477449
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-26
- Public Version
- 2
- Public Version Date
- 2023-03-03
- Public Version Status
- Update
- Public Device Record Key
- ff1d7253-0130-43fa-8b19-29a763eda918
Device Description
A padded device attached to a wheelchair, typically with a long and sturdy metal insert, to provide the wheelchair occupant with a support upon which to rest the head. The device improves user comfort and may improve some user range of vision. Its exterior is typically made of tear-resistant polyurethane. This will also include the extensions needed to attach this device.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IMS | Support, Head And Trunk, Wheelchair | Physical Medicine | 890.3910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41119 | Wheelchair headrest | A padded device attached to a wheelchair, typically with a long and sturdy metal insert, to provide the wheelchair occupant with a support upon which to rest the head. The device improves user comfort and may improve some user range of vision. Its exterior is typically made of tear-resistant polyurethane. This GMDN code will also include the extensions needed to attach this device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00606509900034 | GS1 |