ASEPT Pleural Drainage System

Basic Information

• Brand Name: ASEPT Pleural Drainage System
• Primary DI: 00813623011359
• Version / Model: M7031
• Catalog Number: M7031
• Company Name: PFM MEDICAL INCORPORATED
• Labeler DUNS: 097736867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-02
• Public Version: 4
• Public Version Date: 2019-11-25
• Public Version Status: Update
• Public Device Record Key: a7d4a9b6-8049-433d-b566-41510ea06c01

Device Description

ASEPT Pleural Drainage System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
DWM	Apparatus, Suction, Patient Care	Cardiovascular	870.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10817	Pleural drainage system	An assembly of sterile devices intended to be used for the aspiration of air/fluid from the pleural cavity (potential space between the serous membranes covering the lungs) by means of suction. It includes a pleural catheter, a water seal (underwater) drainage unit, typically with three separate chambers, and typically a suction system regulator, intended to be connected to the hospital's central vacuum system; it does not include pharmaceuticals. This system is usually used to restore normal lung function following chest or mediastinal surgery (e.g., open heart surgery), or to treat conditions such as pneumothorax and/or haemothorax. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813623011356	GS1		5	In Commercial Distribution
Primary	00813623011359	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]