FDA.reportPublic FDA data

Pill Crusher and Splitter Combo

Primary DI
06974567650029
Brand
Pill Crusher and Splitter Combo
Company
GERUI Medical Products Co.,Ltd
Model
GR-009
Catalog number
7103237
Device description
A handheld, non-sterile device intended to split and crush tablets to facilitate oral administration. The device is intended for use only with tablets for which splitting or crushing is permitted according to the drug labeling or healthcare professional instructions.
Published
2026-05-30
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
16974567650026PackageGS1100In Commercial Distribution
06974567650029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697456765002616974567650026
06974567650029069745676500296974567650029

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
544300711
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974567650005Pill Crusher70029IL0810166252026-05-30
06974567650012Pill SplitterGR-0100810166412026-05-30
06974567650036Pill Crusher and Splitter ComboGR-02871032412026-05-30
06974567650043Pill CrusherGR-03071032432026-05-30
06974567650050Pill SplitterGR-02971032422026-05-30

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
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
30850006611264RxCrushRESOLVE DESIGNS LLCOHY2024-12-17