AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 20686864042963
• Version / Model: 53803
• Catalog Number: 53803
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 2
• Public Version Date: 2019-07-22
• Public Version Status: Update
• Public Device Record Key: 216d35d4-d3c8-484f-b72e-e691b9d2f3df

Device Description

AMD-RITMED GT DRAINAGE BAGS WITH SPOUT

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
EYZ	SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62286	Gastric drainage/decompression bag	A plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20686864042963	GS1
Unit of Use	00686864042969	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