FDA.reportPublic FDA data

Luna Twin 400 kg - Winncare

Primary DI
05740008101457
Brand
Luna Twin 400 kg - Winncare
Company
Winncare Nordic ApS
Model
015-03040
Device description
Luna Twin Fixed Ceiling Lift. Wired hand controller. Standard with Two-point spreader bar. Twin port. Twin Safe Working Load 880 Ib (400 kg). Safe Working Load for twin use 606 lb (275 kg).
Published
2025-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05740008101457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05740008101457057400081014575740008101457

GMDN Terms#

Term, Definition table
TermDefinition
Overhead track patient lifting/transfer systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height130Millimeter
Outer Diameter320Millimeter
Weight6700Kilogram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305648687
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05740008101372Luna IPX4 200 kg Portable - Winncare015-030202025-09-01
05740008101389Luna IPX4 275 kg Portable - Winncare015-030222025-09-01
05740008101396Luna IPX4 200 kg Fixed - Winncare015-030262025-09-01
05740008101402Luna IPX4 275 kg Fixed - Winncare015-030282025-09-01
05740008101426Luna IPX4 200 kg ACC port Fixed - Winncare015-030322025-09-01
05740008101433Luna IPX4 275 kg ACC port Fixed - Winncare015-030222025-09-01
05740008102836Luna X5 Celing lift - Winncare015-030502025-09-01

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Primary DI, Brand, Company table
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