Polytech Filter

GUDID B4461007601

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

POLYTECHNIC RESOURCES INC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: B4461007601
• NIH Device Record Key: 9d6a96f6-92c9-42e1-872c-62293f7b1457
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polytech Filter
• Version Model Number: 100760
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 38.8 Millimeter
• Outer Diameter: 38.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4461007600 [Unit of Use]
HIBCC	B4461007601 [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: 2016-11-15

On-Brand Devices [Polytech Filter]

• B446TNN1031: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446TNN1021: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446TNN1011: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446SAMPLES9: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PUL9000N1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PUL9000K1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PUL9000E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PR772505MP1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PR7725051: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PR0224621: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PR0224541: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PMP757NW1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PMP756NX1: DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SI
• B446PMP756EX1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT851E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT8511: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT830E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT8301: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT819E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446PFT8191: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P5559100E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55591001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55581001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• 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
• B446P5551100E1: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• B446P55511001: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
• 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