ASEPT

Basic Information

• Brand Name: ASEPT
• Primary DI: 00813623016972
• Version / Model: M7080
• Catalog Number: M7080
• Company Name: PFM MEDICAL INCORPORATED
• Labeler DUNS: 097736867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 83c06f71-3351-4b7c-bc94-707150c6547c

Device Description

ASEPT 600mL Starter Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
45391	Closed-wound drainage reservoir suction bulb	A sterile device that is used in conjunction with a drainage reservoir (typically a closed-wound type) to create a low negative pressure in the reservoir and the connected drain assisting in the removal of fluids or purulent material. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10813623016979	GS1		5	In Commercial Distribution
Primary	00813623016972	GS1

Customer Contacts

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