Polytech Filter

GUDID B446759WMN1

Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.

POLYTECHNIC RESOURCES INC

Pulmonary function testing kit

• Primary Device ID: B446759WMN1
• NIH Device Record Key: 2cc480a5-7658-4418-ab58-2be07a87358f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polytech Filter
• Version Model Number: 759WMN
• Company DUNS: 825021079
• Company Name: POLYTECHNIC RESOURCES INC
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 30.1 Millimeter
• Outer Diameter: 30.1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B446759WMN0 [Unit of Use]
HIBCC	B446759WMN1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042758

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-01

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• B446P5557100E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55571001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P5556100E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55561001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P5554100E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55541001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55531001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P5551100S1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
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• B446FIL90001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446FIL79581: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS780NW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS759WC1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS758NW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS758NNK1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS757NW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS757NKNW1: DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SI
• B446EBS757EW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS757EB1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756NX1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756NW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756NP1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756NG1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756NB1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756EX1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446EBS756EW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si