Polytech Mouthpiece

GUDID B446N1007540

A device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector). This is a single-use device.

POLYTECHNIC RESOURCES INC

Pulmonary function testing filter/mouthpiece

• Primary Device ID: B446N1007540
• NIH Device Record Key: 218df938-f770-4e66-8bdd-1ecaa24ed998
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polytech Mouthpiece
• Version Model Number: N100754
• Company DUNS: 825021079
• Company Name: POLYTECHNIC RESOURCES INC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B446N1007540 [Unit of Use]
HIBCC	B446N1007541 [Primary]

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-13
• Device Publish Date: 2020-07-03

Devices Manufactured by POLYTECHNIC RESOURCES INC

• B446756W0 - POLYTECH FILTER: 2021-11-02 Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
• B446100759EN0 - Polytech Filter: 2021-08-31 DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.
• B446M100780E20 - Polytech Filter: 2021-08-31 DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.
• B446S100757NW0 - Polytech Filter: 2021-05-04 DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.
• B446100780EL0 - Polytech Filter: 2021-03-02 Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
• B446M100780EW0 - Polytech Filter: 2021-03-02 Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
• B446M100780W0 - Polytech Filter: 2021-03-02 Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
• B446N100756NKNS0 - Polytech Filter: 2021-03-02 Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.