FDA.reportPublic FDA data

Mor-Medical New Era

Primary DI
00850010988092
Brand
Mor-Medical New Era
Company
Moroles Investments, LLC
Model
DNE-610-4L-BAR
Device description
"Deluxe New Era Patented Infection Control Bariatric 26"" Shower Commode Chair, with Open Front Soft Seat and Insert, Slide Out Commode Pail, 4"" All Locking Casters, 610 lbs. wt. capacity"
Published
2024-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010988092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010988092008500109880928500109880920850010988092

GMDN Terms#

Term, Definition table
TermDefinition
Commode, manualA non-active, manually-operated transportable device in the form of a chair with a built-in receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., during shower). Also known as a sanichair, it may include hydraulically-assisted seat height adjustment, and may or may not be supplied with wheels (castors).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
045103307
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850010988085Mor-Medical New EraDNE-310-3TWL-DDA2024-07-16
00850010988122Mor-Medical New EraDNE-710-4L-FF2024-07-16
00850010988351Mor-Medical New EraDNE-310-3TWL-FF-DDA2024-07-16
00850010988474Mor-Medical New EraDNE-385-3TWL-FF2024-07-16
00850010988849Mor-Medical New EraDNE-385-3TWL-DDA2024-07-16
00858288006203Mor-Medical New EraDNE-385-3TWL2024-07-16
00858288006326Mor-Medical New EraDNE-310-3TWL2024-07-16
00850010988320Mor-Medical New EraDNE-CCRT-102024-07-18
00850010988764Mor-Medical New EraDNE-SG102024-07-17
00850010988788Mor-Medical New EraDNE-TB-STD2024-07-17
00850010988795Mor-Medical New EraDNE-TB-H2024-07-17
00850010988702Mor-Medical New EraDNE-REC-335-FF-LR-PAIL2024-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06