FDA.reportPublic FDA data

BOUNDER Plus

Primary DI
00861980000486
Brand
BOUNDER Plus
Company
21ST CENTURY SCIENTIFIC, INC.
Model
Manual Gurney
Published
2023-06-11
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
00861980000486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861980000486008619800004868619800004860861980000486

GMDN Terms#

Term, Definition table
TermDefinition
Assistive wheeled stretcherA manually-operated device designed as a wheeled stretcher with a platform made for a person with a disability in a lying position to transport themselves around. It has a flat top surface upon which the user lies on their stomach and four wheels. It is available in a variety of designs, e.g., having two large hand-propelled wheelchair type wheels at the front which also provides a steering capability, or it can be very low so that the user propels and steers by pushing directly on the floor. It will provide a person with a disability with a means of limited mobility typically without presence of an attendant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
099447922
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
00861980000400BounderBOUNDER PLUS2017-07-05
00861980000417BounderBIG BOUNDER2017-07-05
00861980000493BOUNDER PlusPower Gurney2023-06-12
00861980000431BOUNDERBOUNDER 3002020-09-24
00861980000448BOUNDERBOUNDER PLUS 3002020-09-24
00861980000455BOUNDERBOUNDER 4502020-09-24
00861980000462BOUNDERBIG BOUNDER 6002020-09-24
00861980000479BOUNDERBIG BOUNDER 10002020-09-24
00861980000424BounderBOUNDER 300M2018-08-14

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