Polytech Noseclip

GUDID B446N100753S0

A device intended to be used to compress the nose externally, to ensure that airflow is exclusively conducted through the mouth during examinations of the pulmonary function (e.g., spirometry), and/or to stop nosebleeds (epistaxis). It is typically constructed of plastic with rubber or foam tips. This is a single-use device.

POLYTECHNIC RESOURCES INC

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• Primary Device ID: B446N100753S0
• NIH Device Record Key: 43230cd6-5d0e-4d32-9482-ed94afa20aa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polytech Noseclip
• Version Model Number: N100753S
• Company DUNS: 825021079
• Company Name: POLYTECHNIC RESOURCES INC
• Device Count: 100
• 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	B446N100753S0 [Unit of Use]
HIBCC	B446N100753S1 [Primary]

FDA Product Code

• BXJ: Clip, Nose

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: 2020-12-28
• Device Publish Date: 2020-12-18

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.