FDA.reportPublic FDA data

RxCrush

Primary DI
30850006611011
Brand
RxCrush
Company
RESOLVE DESIGNS LLC
Model
PP06-50
Catalog number
PP06
Device description
RxCrush Pill Pouch, 3"x5", 50ml, ENFit. Pill Pouch with locking ENFit for pill crushing.
Published
2024-12-17
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850006611017PackageGS15In Commercial Distribution
30850006611011PackageGS11000In Commercial Distribution
50850006611015PackageGS14000In Commercial Distribution
70850006611019PackageGS172000In Commercial Distribution
00850006611010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000661101710850006611017
3085000661101130850006611011
5085000661101550850006611015
7085000661101970850006611019
00850006611010008500066110108500066110100850006611010

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of sunlight. Keep out of moisture.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877.343.2783info@rxcrush.com

Regulatory Flags#

DUNS number
091290281
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
false
Expiration date on label
false
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
00850006611867RxCrushCA04-100CA042025-04-30
30850006611868RxCrushCA04-100CA042025-04-30
00850006611010RxCrushPP06-50PP062024-12-17
00850006611027RxCrushEO05-100EO052024-12-17
00850006611034RxCrushPC11-ENPC112024-12-17
00850006611058RxCrushCA03-100CA032024-12-17
00850006611096RxCrushPP20-100PP202024-12-17
00850006611102RxCrushCA02-100CA022024-12-17
00850006611126RxCrushEL02-100EL022024-12-17
00850006611140RxCrushEO02-100EO022024-12-17
00850006611157RxCrushET01-100ET012024-12-17
00850006611164RxCrushPP10-50PP102024-12-17
00850006611171RxCrushEC06-50EC062024-12-17
00850006611195RxCrushPP08-50PP082024-12-17
00850006611256RxCrushPC11-REFPC112024-12-17
00850006611263RxCrushPC11-SPPC112024-12-17
00850006611300RxCrushPC11-FRPC112024-12-17
00850006611836RxCrushPC16-1PC162024-12-17
00850006611843RxCrushPP11-5PP112024-12-17
00850006611850RxCrushPP142024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30813360023654UnoDoseCordica Medical, Inc.KYX2026-10-22
40813360023651UnoDoseCordica Medical, Inc.KYX2026-10-22
10813360023643UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023674UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023681UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023640UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023657UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023671UnoDoseCordica Medical, Inc.KYX2026-10-20
20813360023688UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023647UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023678UnoDoseCordica Medical, Inc.KYX2026-10-20
30813360023685UnoDoseCordica Medical, Inc.KYX2026-10-20
40813360023644UnoDoseCordica Medical, Inc.KYX2026-10-20
10813360023667UnoDoseCordica Medical, Inc.KYX2026-10-06
20813360023664UnoDoseCordica Medical, Inc.KYX2026-10-06
30813360023661UnoDoseCordica Medical, Inc.KYX2026-10-06
MHC18140012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18140602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340012EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340032EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340052EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340102EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340202EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340302EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22
MHC18340602EasyTouchMHC MEDICAL PRODUCTS, LLCKYX2026-09-22