FDA.reportPublic FDA data

HCS

Primary DI
00810132043666
Brand
HCS
Company
Concordance Healthcare Solutions LLC
Model
0232
Device description
Pill Cutter & Crusher Combo
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OHYPill Crusher/Cutter

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810132043663PackageGS15In Commercial Distribution
30810132043667PackageGS150In Commercial Distribution
00810132043666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081013204366310810132043663
3081013204366730810132043667
00810132043666008101320436668101320436660810132043666

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
080220245
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132043789HCS9201-5002026-05-13
00810132043796HCS9201-10002026-05-13
00810132044359HCS3004OHCB23004OHCB22026-03-09
00810132044366HCS Sourcing3004OTCB2XL3004OHCB2XL2026-03-09
00810132044335HCS3011SHU3011SHU2026-03-09
00810132044342HCS3011SHXL3011SHXL2026-03-09
10810132044332HCS3011SHU3011SHU2026-03-09
10810132044349HCS3011SHXL3011SHXL2026-03-09
10810132044356HCS3004OHCB22026-03-09
20810132044360HCS Sourcing3004OTCB2XL2026-03-09
10810132043717HCS6605W2026-01-30
10810132043724HCS6606W2026-01-30
00810132040030HCSHCS40032023-04-21
00810132040047HCSHCS40042023-04-21
00810132040979HCSHCS40012023-04-21
00810132040986HCSHCS40022023-04-21
20810132043714HCS6605W2026-01-30
20810132043721HCS6606W2026-01-30
00810132043000HCS818012026-01-23
00810132043017HCS818022026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
30850006611264RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
30850006611301RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
30850006611837RxCrushRESOLVE DESIGNS LLCOHY2024-12-17
10840330701348ProCureTwin Med, LLCOHY2024-11-14
00087701190575ApexDrive Devilbiss HealthcareOHY2024-11-14
20087701190579ApexCOMPASS HEALTH BRANDS CORP.OHY2024-11-14
00087701190582ApexDrive Devilbiss HealthcareOHY2024-11-14