FDA UDI
In Commercial Distribution
🇺🇸 United States
Whitmyer
DI: 00016958050318
·
Model: Whitmyer
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Whitmyer
- Primary DI
- 00016958050318
- Version / Model
- Whitmyer
- Catalog Number
- E0955
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-05
- Public Version
- 1
- Public Version Date
- 2023-09-13
- Public Version Status
- New
- Public Device Record Key
- 22295a08-60af-42cf-bac7-5831820aae03
Device Description
This basic wheelchair headrest is ideal for tilt or recline, accepts additional lateral and anterior supports, and is easily adjustable to adapt with clients as their needs change.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00016958050318 | GS1 |