SmartTap™ Paracentesis Drainage Bag, 4L

Basic Information

• Brand Name: SmartTap™ Paracentesis Drainage Bag, 4L
• Primary DI: 36641670005589
• Version / Model: 3.8
• Catalog Number: CM-0020
• Company Name: Cardiomed Supplies Inc
• Labeler DUNS: 240623124
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-11-27
• Public Version: 1
• Public Version Date: 2020-12-07
• Public Version Status: New
• Public Device Record Key: 957884e8-93a5-475c-840b-7ad7fdcc0340

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
EYZ	System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile	Gastroenterology, Urology	876.5250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64908	Abdominal fistula drainage supplementary bag	A plastic pouch intended to be connected to an abdominal fistula drainage set (not included) to supplement the set’s capacity for fluid or purulent material collection and removal during drainage/healing of a large fistula or wound; it may in addition be connected to an intestinal ostomy bag. It is not a primary collection device and is not intended to be attached directly to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	16641670005578	GS1
Primary	36641670005589	GS1