FDA UDI
In Commercial Distribution
🇺🇸 United States
Luna IPX4 200 kg ACC port Fixed - Winncare
DI: 05740008101426
·
Model: 015-03032
·
Winncare Nordic ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Luna IPX4 200 kg ACC port Fixed - Winncare
- Primary DI
- 05740008101426
- Version / Model
- 015-03032
- Company Name
- Winncare Nordic ApS
- Labeler DUNS
- 305648687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-01
- Public Version
- 1
- Public Version Date
- 2025-09-09
- Public Version Status
- New
- Public Device Record Key
- 971ea4fb-c142-4fa4-a0c1-1c41c8803576
Device Description
Luna IPX4 Fixed Ceiling Lift. Wired hand controller. Standard with Two-point spreader bar. Accessory port. Safe Working Load 440 Ib (200 kg).
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
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
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 |
|---|---|---|---|---|
| 38129 | Overhead track patient lifting/transfer system | A electrically-powered assembly of devices designed to enable an incapacitated patient or a person with a disability to be lifted/moved (transferred) safely and with minimal physical effort within the confines of one floor of a building, typically an institution or the person's home. It typically consists of ceiling-mounted track, and a motorized hoist and patient holding device (e.g., a sling, holder or a frame) for lifting and lowering the patient, that can be moved along the overhead track. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05740008101426 | GS1 |
Customer Contacts
- Phone
- +4570273720
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 230 | Millimeter | |
| Weight | 6700 | Gram | |
| Outer Diameter | 320 | Millimeter |