ASEPT

Basic Information

• Brand Name: ASEPT
• Primary DI: 00813623015746
• Version / Model: M7052
• Catalog Number: M7052
• 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: 2ebffa86-6cc1-49f3-a956-4efcc1f5bf2a

Device Description

ASEPT 600mL Drainage Bottle with Y-Site Drain

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	10813623015743	GS1		10	In Commercial Distribution
Primary	00813623015746	GS1

Customer Contacts

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