Pentair

Basic Information

• Brand Name: Pentair
• Primary DI: B46200080020115
• Version / Model: 0008002011
• Catalog Number: DPC2011S500C
• Company Name: PENTAIR FILTRATION SOLUTIONS, LLC
• Labeler DUNS: 057656759
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-12-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fd666273-b041-41b4-9334-fd0517894ec2

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Cardiovascular	870.4280	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36080	Cardiopulmonary bypass system filter, priming solution	A porous, sterile device intended to be used to filter the nonhaemic priming solution used in the heart-lung bypass extracorporeal circuit to remove particulates or other debris from the circuit prior to the initiation of the cardiopulmonary bypass surgery procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B46200080020115	HIBCC
Unit of Use	B46200080020110	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982385	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit