FDA.reportPublic FDA data

HCS

Primary DI
10849027004045
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS0235
Device description
Pill Crusher, Latex Free
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

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
10849027004045PackageGS1240In Commercial Distribution
00849027004048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700404510849027004045
00849027004048008490270040488490270040480849027004048

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 normally available [non-prescription] over-the-counter (OTC) and designed for convenience to be carried in the user's pocket or handbag (purse). It 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078572603
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

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