FDA UDI
In Commercial Distribution
🇺🇸 United States
Traxx Mobility Systems
DI: 00850056676014
·
Model: Titan 500
·
Traxx Mobility Systems LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Traxx Mobility Systems
- Primary DI
- 00850056676014
- Version / Model
- Titan 500
- Company Name
- Traxx Mobility Systems LLC
- Labeler DUNS
- 025612885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-26
- Public Version
- 1
- Public Version Date
- 2023-11-03
- Public Version Status
- New
- Public Device Record Key
- db3c33a3-9e82-4fc1-8537-9cac9442aeb9
Device Description
10-foot-wide freestanding patient lift system
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
- 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 |
|---|---|---|---|---|
| FSA | Lift, patient, non-ac-powered | General Hospital | 880.5510 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30021 | Freestanding patient lifting system, electrically-powered | An electrically-powered, stationary (non-mobile) assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist, it typically consists of a support base (non-fixed and freestanding on the floor) with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, and patient holding device (e.g., a sling, holder or a frame). Repositioning of the assembly may be achieved by lifting it to a new position/location. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056676014 | GS1 |
Customer Contacts
- Phone
- +1(734)744-8100
- [email protected]