FDA.reportPublic FDA data

Mor-Medical New Era

Primary DI
00850010988764
Brand
Mor-Medical New Era
Company
Moroles Investments, LLC
Model
DNE-SG10
Device description
Deluxe New Era Patented Infection Control Soft Touch Shower Gurney with Elevated Head Section, 450 lbs. wt. capacity
Published
2024-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FPOStretcher, Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010988764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010988764008500109887648500109887640850010988764

GMDN Terms#

Term, Definition table
TermDefinition
Bathing stretcherA manually-operated device consisting of a platform mounted on a frame designed to support a recumbent patient for bathing. It is designed to be submerged in an appropriate bath. The device is used primarily for a patient incapable of supporting themself in an upright position for bathing.

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
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
0019079000638935X PROFLEXXFERNO-WASHINGTON, INC.FPO2026-03-24
00190790006570POWER F2FERNO-WASHINGTON, INC.FPO2026-03-24
00190790006600POWER X2FERNO-WASHINGTON, INC.FPO2026-03-24
G782MPC1000Prone CartElectro-Connect, Inc.FPO2026-03-19
00887761005419Dynamo Series StretcherHILL-ROM, INC.FPO2026-02-19
00887761005457Side rail PadHILL-ROM, INC.FPO2026-02-19
00850073470091Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2026-01-27
08592654554524Sprint 100L I N E T spol. s r.o.FPO2026-01-07
00841027102755Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
00841027102762Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
00850073470084Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-10-02
00190790003210POWER X2FERNO-WASHINGTON, INC.FPO2025-09-10
00817492013223NOA Medical IndustriesHoffmann NOA Medical Industries, LLCFPO2025-06-19
M3685B800STPD1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
M3685B800ST1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
00850073470015Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470022Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470039Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470046Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
B237ZTGACA020Zephyr Patient StretcherDiacor, Inc.FPO2025-03-27
06974583360056HeruiZhangJiaGang Herui Medical Equipment Co.,LtdFPO2024-10-14
07613327613643Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327622690Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623444Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623451Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623475Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623482Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
B773KHSTR0KLYOKLYO MEDICAL SYSTEMS INC.FPO2024-02-23
07350016061797TR Stretcher without side rails Tr Equipment ABFPO2023-12-12
07350016061803TR Stretcher incl. side rails R & LTr Equipment ABFPO2023-12-12