Other products from "PULMONX CORPORATION"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 M776CHRCO100 G3 CHR-CO-100 The Pulmonx® Chartis System is designed to measure pressure and flow in order to The Pulmonx® Chartis System is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Console has a touch-screen user interface that is easy to navigate, and a mouse or keyboard is not required. Patient assessment data can be exported to a USB flash memory device. BZG Spirometer, Diagnostic 2 Chartis Console
2 00811907031222 EDC-TS-5.5-DM The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) selfexpanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Delivery Catheter
3 00811907030720 EDC-TS-5.5 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Delivery Catheter
4 00811907030621 EDC-TS-4.0-J The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Delivery Catheter
5 00811907030522 EDC-TS-4.0 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Delivery Catheter
6 00811907031819 LIA-01-001 The Lung Image Analysis (LIA) software is designed to aid in the interpretation The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format. JAK System, X-Ray, Tomography, Computed 2 Lung Image Analysis
7 00811907030423 EBV-TS-5.5-LP The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it throughthe working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Endobronchial Valve
8 00811907030324 EBV-TS-5.5 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Endobronchial Valve
9 00811907030225 EBV-TS-4.0-LP The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Endobronchial Valve
10 00811907030126 EBV-TS-4.0 The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant desig The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. NJK Valve, Pulmonary 3 Zephyr Endobronchial Valve
11 00811907031161 CHR-CO-300 The Chartis Tablet Console is a two-part spirometry system comprised of a touchs The Chartis Tablet Console is a two-part spirometry system comprised of a touchscreen computer and sensor enclosure designed for use in the bronchoscopy suite in conjunction with the Chartis Catheter. The Chartis Catheter is a previously cleared device (under K111522) and the subject 510(k) K180011 is solely for the Chartis Tablet Console. The proximal end of the Chartis Catheter is attached to a polymer tube with a filter whose opposite end is attached to an input fitting on the Chartis Console. Theballoon on the Chartis Catheter isolates the lung compartment of interest. The hardware components of the Tablet Console translate airflow and pressure detected through the Chartis Catheter into electrical signals. The Tablet Console analyzes and displays airflow and pressure from the isolated lung compartment in real time. BZG Spirometer, Diagnostic 2 Pulmonx Chartis Tablet Console
12 M776CHRCA120 G3 CHR-CA-12.0 The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 2 Chartis Catheter
13 00811907030928 G3 CHR-CA-12.0 The Chartis Catheter is a single use, sterile, disposable device designed to be The Chartis Catheter is a single use, sterile, disposable device designed to be inserted into a 2.8mm working channel of a standard video bronchoscope during a diagnostic bronchoscopy procedure. The Chartis Catheter is a hollow catheter shaft made of medical-grade PEBAX. The Chartis Catheter is 169 cm in length with a working length of 72 cm and a 2.7 mm outer diameter. The distal end of the catheter employs an inflatable balloon made from a compliant elastomeric material. The catheter has two lumens: the main lumen allows air flow from the isolated lung compartment to the Console, and the second smaller lumen allows balloon inflation. The proximal end of the catheter has two ports, a balloon inflation port to inflate the distal balloon, and an obturator port with a luer fitting for connection to the Chartis Console via the Connector Set. A custom obturator inserted into the main lumen of the catheter is used for both pushability and to clear mucus that may obstruct the lumen during catheter manipulation in the airways. The only portion of the device that comes into bodily contact is the distal tip of the catheter, which is made from medical grade PEBAX (shaft) and a compliant elastomeric material (balloon). No medicinal substances are eluted from the catheter. CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) 2 Chartis Catheter
Other products with the same Product Code "BZG"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00841709107931 4-000-0028 4-000-0028 The Midmark Digital Spirometer is intended for prescription-use only by physicia The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips, calibration syringe. Midmark Digital Spirometer w/Calibration Syringe MIDMARK CORPORATION
2 00841709107924 4-000-0027 4-000-0027 The Midmark Digital Spirometer is intended for prescription-use only by physicia The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Kit contains: digital spirometer, 10 single mouthpieces, one (1) ten pack of nose clips. Midmark Digital Spirometer MIDMARK CORPORATION
3 00841709107917 1-100-1235 1-100-1235 The Midmark Digital Spirometer is intended for prescription-use only by physicia The Midmark Digital Spirometer is intended for prescription-use only by physicians and professional medical personnel to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in hospitals and physician/clinician offices. Midmark Digital Spirometer MIDMARK CORPORATION
4 00841709100376 1-100-1225 1-100-1225 The IQspiro® Digital Spirometer is intended for use as a prescription-use-only c The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software. Midmark IQspiro® Digital Spirometer MIDMARK CORPORATION
5 00841709100345 4-000-0025 4-000-0025 The IQspiro Digital Spirometer is intended for use as a prescription-use-only cl The IQspiro Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro operates with a Windows-compatible computer using a USB port connection and the Midmark software. Kit includes: Midmark IQspiro Digital Spirometer, 10 Disposable Spirometer Mouthpieces, 10 Disposable Nose clips, and Carrying Case. Midmark IQspiro Digital Spirometer MIDMARK CORPORATION
6 00841709100338 4-000-0026 4-000-0026 The IQspiro® Digital Spirometer is intended for use as a prescription-use-only c The IQspiro® Digital Spirometer is intended for use as a prescription-use-only clinical diagnostic spirometer for pulmonary function evaluation and data management. The IQspiro® is for use in hospitals and physician/clinician offices by individuals that have received instruction or training in the administration of spirometry tests. The IQspiro® operates with a Windows-compatible computer using a USB port connection and the Midmark software. This Kit contains the IQcal® 3-Litre Calibration Syringe. Midmark IQspiro® Digital Spirometer with Calibration Syringe MIDMARK CORPORATION
7 00812574026429 301-PFR9WNC FILTER,C/B M/P,N/C,27.0ID,30.1OD Curaplex TRI-ANIM HEALTH SERVICES, INC.
8 00812574026412 301-PFR9WN FILTER,N/C,27.0 ID,30.1OD Curaplex TRI-ANIM HEALTH SERVICES, INC.
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29 00812574025033 301-PFR80WKN FILTER,RUB M/P,N/C,30.5ID,34OD 100/BX Curaplex TRI-ANIM HEALTH SERVICES, INC.
30 00812574025019 301-PFR60WK FILTER,RUB M/P,34.5ID,38.8OD 100/BX Curaplex TRI-ANIM HEALTH SERVICES, INC.
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