RxCrush

Basic Information

• Brand Name: RxCrush
• Primary DI: 00850006611058
• Version / Model: CA03-100
• Catalog Number: CA03
• Company Name: RESOLVE DESIGNS LLC
• Labeler DUNS: 091290281
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-17
• Public Version: 1
• Public Version Date: 2024-12-25
• Public Version Status: New
• Public Device Record Key: d1818164-3315-4961-9964-727472af0169

Device Description

Female ENFit Pill Pouch Cap - Screw-on. Use to seal RxCrush Pill Pouch to store and transport medication.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65012	ENFit-formatted protective cap	A small, noninvasive, closed-ended, ENFit-formatted (ISO 80369-3) attachment intended to be attached to an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30850006611059	GS1	Box	1000	In Commercial Distribution
Primary	00850006611058	GS1
Package	10850006611055	GS1	SAMPLE	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep out of sunlight. Keep out of moisture.