FDA.reportPublic FDA data

Mor-Medical New Era

Primary DI
00858288006203
Brand
Mor-Medical New Era
Company
Moroles Investments, LLC
Model
DNE-385-3TWL
Device description
"Deluxe New Era Patented Infection Control 22"" Shower Chair, with Open Front Soft Seat and Insert, Slide Out Commode Pail, 3"" All Locking Casters, 385 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
00858288006203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858288006203008582880062038582880062030858288006203

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
00850010988092Mor-Medical New EraDNE-610-4L-BAR2024-07-16
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
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

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00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
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