FDA.reportPublic FDA data

Mor-Medical New Era

Primary DI
00850010988702
Brand
Mor-Medical New Era
Company
Moroles Investments, LLC
Model
DNE-REC-335-FF-LR-PAIL
Device description
"Deluxe New Era Patented Infection Control 20"" Reclining Shower Chair with Open Front Soft Seat and Insert, Soft Touch Folding Footrest and Legrest, Slide Out Commode Pail, 3"" All Locking Casters, 335 lbs. wt. capacity "
Published
2024-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010988702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010988702008500109887028500109887020850010988702

GMDN Terms#

Term, Definition table
TermDefinition
Reclining chairA manually-operated, general-purpose device designed to support a patient in a seated position; it includes a back rest that reclines for patient comfort. The chair is intended to be used in a variety of settings including recovery from minor procedures, during convalescence, while donating blood, or while receiving chemotherapy. It may have a height-adjustable mechanism and have attached armrests, footrests, and/or legrests.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
05715393055838R82R82 A/SINN2026-03-26
05715393078868R82R82 A/SINN2026-03-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00860014545825Peri-Chair LLCPERI-CHAIR, LLCINN2025-10-15
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
05707581000751Shower SeatRopox A/SINN2022-12-08
05707581000768Shower SeatRopox A/SINN2022-12-08
05707581000775Shower SeatRopox A/SINN2022-12-08
05707581000782Shower SeatRopox A/SINN2022-12-08
07320451321794Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451321817Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451351173Etac Supply Center ABEtac Supply Center ABINN2022-12-08
00850001752169Compass Chair Size 1RIFTON EQUIPMENTINN2022-09-16
00850001752176Compass Chair Size 2RIFTON EQUIPMENTINN2022-09-16