NA

Basic Information

• Brand Name: NA
• Primary DI: 00650862199079
• Version / Model: 19907
• Company Name: Atrium Medical Corporation
• Labeler DUNS: 051798999
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2020-10-15
• Public Version Status: Update
• Public Device Record Key: 9db1d50b-fdae-4c23-b4c7-0cdb72c193a3

Device Description

PATIENT TUBE PACK, NON-LATEX, 3/8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDQ	BOTTLE, COLLECTION, VACUUM	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32544	Mediastinal drainage catheter, non-antimicrobial	A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20650862199073	GS1		10	In Commercial Distribution
Primary	00650862199079	GS1