FDA.reportPublic FDA data

RxCrush

Primary DI
30850006611196
Brand
RxCrush
Company
RESOLVE DESIGNS LLC
Model
PP08-50
Catalog number
PP08
Device description
RxCrush Pill Pouch, 2"x3", 30ml, 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
10850006611192PackageGS15In Commercial Distribution
30850006611196PackageGS11000In Commercial Distribution
50850006611190PackageGS14000In Commercial Distribution
70850006611194PackageGS172000In Commercial Distribution
00850006611195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000661119210850006611192
3085000661119630850006611196
5085000661119050850006611190
7085000661119470850006611194
00850006611195008500066111958500066111950850006611195

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

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