FDA UDI
In Commercial Distribution
🇺🇸 United States
Proactive
DI: 06974512010014
·
Model: 32475
·
XIAMEN WORLD GEAR SPORTS GOODS CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Proactive
- Primary DI
- 06974512010014
- Version / Model
- 32475
- Company Name
- XIAMEN WORLD GEAR SPORTS GOODS CO., LTD
- Labeler DUNS
- 529314858
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-18
- Public Version
- 1
- Public Version Date
- 2023-07-26
- Public Version Status
- New
- Public Device Record Key
- 9f1707f5-c77b-48ee-8572-1fd191ffd8d9
Device Description
The Proactive Medical patient lift is intended to transfer an individual from one resting surface to another (such as a bed to a wheelchair).
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 45678 | Mobile patient lifting system, manual | A non-powered, 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. Also known as a patient hoist, it typically consists of a support base on wheels with a lifting mechanism, mast, boom, swivel bar, and patient holding device (e.g., a sling, holder or a frame). The lifting mechanism provides mechanical advantage (e.g., using pneumatic springs) to aid manual movement of components. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974512010014 | GS1 |