ASEPT

Basic Information

• Brand Name: ASEPT
• Primary DI: 00813623017047
• Version / Model: M7004
• Catalog Number: M7004
• Company Name: PFM MEDICAL INCORPORATED
• Labeler DUNS: 097736867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-31
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: a06b6fc7-6af7-43b5-b471-a15d1a47d089

Device Description

ASEPT Replacement Valve

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: Yes
• 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
PNG	Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling	Gastroenterology, Urology	876.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62752	Pleural drainage valve	A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20813623017041	GS1		20	In Commercial Distribution
Package	10813623017044	GS1		5	In Commercial Distribution
Primary	00813623017047	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K093796	000