Polytech Filter

Basic Information

• Brand Name: Polytech Filter
• Primary DI: B446757ELMSN1
• Version / Model: 757ELMSN
• Company Name: POLYTECHNIC RESOURCES INC
• Labeler DUNS: 825021079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-11-27
• Public Version: 1
• Public Version Date: 2018-12-28
• Public Version Status: New
• Public Device Record Key: 67aca055-5ffc-4d18-83a1-193dc6794154

Device Description

DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.

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: Yes
• Has Lot/Batch Number: No
• 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
BZG	Spirometer, Diagnostic	Anesthesiology	868.1840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60506	Pulmonary function testing kit	A collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B446757ELMSN1	HIBCC
Unit of Use	B446757ELMSN0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K042758	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	34.3	Millimeter