AMD-RITMED SOLON

Basic Information

• Brand Name: AMD-RITMED SOLON
• Primary DI: 10686864049118
• Version / Model: 56800
• Catalog Number: 56800
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 5
• Public Version Date: 2023-05-31
• Public Version Status: Update
• Public Device Record Key: 060a0bcb-2bde-428c-99f9-c51c19631bdc
• Distribution End Date: 2023-05-30

Device Description

AMD-RITMED SOLON COTTON TIP APPLICATORS 6 inch Sterile

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXG	APPLICATOR, ABSORBENT TIPPED, STERILE	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	12686864049116	GS1	Inner Box	100	Not in Commercial Distribution	2022-02-10
Primary	10686864049118	GS1
Package	20686864049115	GS1	Outer Case	10	Not in Commercial Distribution	2023-05-30
Unit of Use	00686864049111	GS1
Package	30686864049112	GS1	Inner Box	100	Not in Commercial Distribution	2023-05-30

Customer Contacts

• Phone: [phone] ext. 2309
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature
• Type: Storage Environment Humidity
• Temperature Range: High: 80 Percent (%) Relative Humidity