FDA.reportPublic FDA data

Avaline Medical NJ LLC

Primary DI
00810077210154
Brand
Avaline Medical NJ LLC
Company
Avaline Medical NJ Limited Liability Company
Model
VKPCP0100
Catalog number
VKPCP0100
Device description
Pill Crusher Pouches
Published
2021-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00810077210154PrimaryGS10
00810077210147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077210154008100772101548100772101540810077210154
00810077210147008100772101478100772101470810077210147

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.

Contacts#

Phone, Email table
PhoneEmail
+1(732)813-7799jstein@avalinemedical.com

Regulatory Flags#

DUNS number
079767953
Device count
48
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810077219904Avaline Medical NJ LLCVKAEP202023-11-04
00810077219911Avaline Medical NJ LLCVKAEP402023-11-04
00810077219928Avaline Medical NJ LLCVKAEP602023-11-04
00810077219935Avaline Medical NJ LLCVKAEP1202023-11-04
00810077219942Avaline Medical NJ LLCVKAEP2402023-11-04
00810077219959Avaline Medical NJ LLCVKAEP4802023-11-04
00810124536794Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536831Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536855Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536886Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536787Avaline Medical NJ LLCVK97245VK972452025-12-05
00810124536824Avaline Medical NJ LLCVK97223VK972232025-12-05
00810124536848Avaline Medical NJ LLCVK15236VK152362025-12-05
00810124536879Avaline Medical NJ LLCVK15296VK152962025-12-05
00810124536909Avaline Medical NJ LLCVK69576VK695762025-12-05
00810124536923Avaline Medical NJ LLCVK45915VK459152025-12-05
00810124531843Avaline Medical NJ LLC1lb C-Rollx32025-09-03
00810124532116Avaline Medical NJ LLCOEP x252025-09-03
00810124532123Avaline Medical NJ LLCOEP x502025-09-03
00810124532130Avaline Medical NJ LLCOEP x1002025-09-03

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