FDA.reportPublic FDA data

Monty 3D Plus HD

Primary DI
B8961143120
Brand
Monty 3D Plus HD
Company
REHAdapt Engineering GmbH & Co. KG
Model
11.4312
Device description
"M3D wheelchair mount with the longest reach and the most stability. Tube lengths 500 x 500 x 400 mm (20 x 20 x 16""). UDS-DC and additional 300 mm (12"") tube included. Max. load capacity: 6.0 kg (13.2 lbs). Frame clamp not included."
Published
2022-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNOAccessories, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNOAccessories, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8961143120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Portable active medical device mountA device intended to be fixed within a clinical setting (e.g., healthcare facility wall, ambulance, trolley) to enable easy and secure short-term and/or long-term mounting of a portable active medical device (e.g., an electronic/electromechanical device such as a barcode reader, emergency suction system, humidifier, resuscitator) during use; the parent device is not included. It may be dedicated to mounting a specific parent device, or non-dedicated. It may in addition allow for integration of a power cable, which may be included; it may provide for storage of the device but is not a dedicated storage mount.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
340146982
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8961122110Monty 3D TT11.22112022-07-26
B8961123120Monty 3D TT Plus11.23122022-07-26
B8961131000Monty 3D11.31002022-07-26
B8961132110Monty 3D QuickShift11.32112022-07-26
B8961133110Monty 3D QuickShift Sturdy11.33112022-07-26
B8961133120Monty 3D Plus11.33122022-07-26
B8961153110Monty 3D Curved M11.53112022-07-26
B8961163120Monty 3D Curved L11.63122022-07-26
B8961173120Monty 3D Curved XL11.73122022-07-26

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