FDA UDI
In Commercial Distribution
🇺🇸 United States
Invacare® TDXSP2-HD with Captains Seat
DI: 00841447102052
·
Model: TDXSP2V-HD
·
INVACARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Invacare® TDXSP2-HD with Captains Seat
- Primary DI
- 00841447102052
- Version / Model
- TDXSP2V-HD
- Company Name
- INVACARE CORPORATION
- Labeler DUNS
- 076916246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-24
- Public Version
- 2
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- fab1c5cb-f88d-41de-8875-01b00e681b4a
Device Description
TDXSP2-HD with Captain's Seat
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| ITI | Wheelchair, powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41875 | Electric-motor-driven wheelchair, occupant-controlled | An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841447102052 | GS1 |
Customer Contacts
- Phone
- +1(440)329-6000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182946 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adult/Bariatric |