FDA.reportPublic FDA data

Millennium 5

Primary DI
00815871020527
Brand
Millennium 5
Company
Avante
Model
7JE200
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00815871020527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871020527008158710205278158710205270815871020527

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic stretcherA manually-operated device consisting of a platform mounted on a wheeled frame designed to transport recumbent, immobilized patients with suspected neural axis injuries to or within a hospital.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-244-4444devicehelp@dremed.com

Regulatory Flags#

DUNS number
178440426
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871021647VISION LEDDRE 0615122016-09-23
00815871021685VISION LEDDRE 061512-V2016-09-23
00815871021722VISION EX5DRE 0614122016-09-23
00815871021807Vista LEDDRE 0613122016-09-23
00815871021845Vista LEDDRE 061312-V2016-09-23
00815871022163VISION LEDDRE 0615222017-01-31
00815871022200VISION LEDDRE 061522-V2017-02-01
00815871022248VISION EX5DRE 0614222017-02-01
00815871022286VISION EX5DRE 061422-V2017-02-01
00815871022323Vista LEDDRE 0613222017-02-01
00815871022361Vista LEDDRE 061322-V2017-02-01
00815871020008ASG 12071250ASG2016-09-23
00815871020015ASG 12071250ASGR2016-09-23
00815871020022ASG 2007200ASG2016-09-23
00815871020039ASG 2007200ASGR2016-09-23
00815871020046ASG 3007300ASG2016-09-23
00815871020053ASG 3007300ASGR2016-09-23
00815871021432EG-30070300MB2016-09-23
00815871021449EG-Pro70S4002016-09-23
00815871020107Nasal CO2 Sampling Cannula With O2 DeliveryP03082D2016-09-23

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
00850010988764Mor-Medical New EraMoroles Investments, LLCFPO2024-07-17
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