POLYTECHNIC RESOURCES, INC.

Matched from indexed company URL: POLYTECHNIC RESOURCES INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30071287243007128724POLYTECHNIC RESOURCES, INC.1N2026-01-01198 Venture Drive Seaford DE US 19973

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1132301886434983K042758POLYTECH PULMONARY FUNCTION FILTERBZG2005-08-29
1132301181469507
1132301761173098

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
BZG12005-08-29

PMN#

GUDID#

Polytech Mouthpiece - 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

2020-07-03

Polytech Mouthpiece - 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

2020-07-03

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