FDA.reportPublic FDA data

HealthSmart

Primary DI
00041298154372
Brand
HealthSmart
Company
D-M-S HOLDINGS, INC.
Model
640-5437-0000HS
Device description
Pill Cutter
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHYPill Crusher/Cutter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHYPill Crusher/CutterGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10041298154379PackageGS1400In Commercial Distribution
00041298154372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004129815437910041298154379
00041298154372000412981543720412981543720041298154372

GMDN Terms#

Term, Definition table
TermDefinition
Pill crusher/splitterA hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device.

Regulatory Flags#

DUNS number
062028220
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041298995326DMI619-5140-19002026-06-05
00767056160026MABIS01-160-02101-160-0212016-09-23
00767056160088MABIS01-160-08101-160-0812016-09-23
00767056160156MABIS01-160-15101-160-1512016-09-23
00767056160200MABIS01-160-20101-160-2012016-09-23
00767056160217MABIS01-160-21101-160-2112016-09-23
00767056160248MABIS01-160-24101-160-2412016-09-23
00767056410176MABIS09-141-01709-141-0172016-09-23
00767056110212MABIS01-110-02101-110-0212016-09-23
00767056234017MABIS05-234-01005-234-0102016-09-23
00767056300118MABIS01-130-01101-130-0112016-09-23
00767056300156MABIS01-130-01501-130-0152016-09-23
00767056300163MABIS01-130-01601-130-0162016-09-23
00767056322059MABIS05-223-06005-223-0602016-09-23
00767056400115MABIS01-140-01101-140-0112016-09-23
00767056400139MABIS01-140-01301-140-0132016-09-23
00767056400153MABIS01-140-01501-140-0152016-09-23
00767056400160MABIS01-140-01601-140-0162016-09-23
00767056400177MABIS01-140-01701-140-0172016-09-23
00767056550117MABIS01-155-01101-155-0112016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974567650005Pill CrusherGERUI Medical Products Co.,LtdOHY2026-05-30
06974567650012Pill SplitterGERUI Medical Products Co.,LtdOHY2026-05-30
06974567650029Pill Crusher and Splitter ComboGERUI Medical Products Co.,LtdOHY2026-05-30
06974567650036Pill Crusher and Splitter ComboGERUI Medical Products Co.,LtdOHY2026-05-30
06974567650043Pill CrusherGERUI Medical Products Co.,LtdOHY2026-05-30
06974567650050Pill SplitterGERUI Medical Products Co.,LtdOHY2026-05-30
00850015884696easycareSynchronis Medical, LLCOHY2026-01-23
00850015884719easycareSynchronis Medical, LLCOHY2026-01-23
00850015884733easycareSynchronis Medical, LLCOHY2026-01-23
00850015884702easycareSynchronis Medical, LLCOHY2026-01-23
00850015884726easycareSynchronis Medical, LLCOHY2026-01-23
00850015884740easycareSynchronis Medical, LLCOHY2026-01-23
00810132043659HCSConcordance Healthcare Solutions LLCOHY2025-12-17
00810132043666HCSConcordance Healthcare Solutions LLCOHY2025-12-17
00810132043673HCSConcordance Healthcare Solutions LLCOHY2025-12-17
10810132043656HCSConcordance Healthcare Solutions LLCOHY2025-12-17
30810132043667HCSConcordance Healthcare Solutions LLCOHY2025-12-17
10810132043670HCSConcordance Healthcare Solutions LLCOHY2025-12-17
00827989007802Health Care Logistics, Inc®Health Care Logistics, Inc.OHY2025-12-03
00827989007819Health Care Logistics, Inc®Health Care Logistics, Inc.OHY2025-12-03
10827989003986Health Care Logistics, Inc®Health Care Logistics, Inc.OHY2025-03-13
10827989007519Health Care Logistics, Inc®Health Care Logistics, Inc.OHY2025-03-13
G40935950Primary CareEVANS MANUFACTURING, INC.OHY2025-02-24
00850006611034RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
00850006611256RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
00850006611263RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
00850006611300RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
00850006611836RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
30850006611035RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
10850006611253RxCrushRESOLVE DESIGNS LLCOHY2024-12-17