AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864048029
• Version / Model: 2213
• Catalog Number: 2213
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 3
• Public Version Date: 2022-07-29
• Public Version Status: Update
• Public Device Record Key: 75057e17-fc76-49d7-b66d-f25fd5622f86

Device Description

AMD-RITMED COUNTWAY SYSTEM PANEL WITH POCKETS

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LWH	Counter, sponge, surgical	General Hospital	880.2740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61453	Surgical sponge-counting tray	A device in the form of a tray intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a tray with individual sections; it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864048026	GS1	Outer Case	8	In Commercial Distribution
Primary	10686864048029	GS1
Unit of Use	00686864048022	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place