Polytech Filter

GUDID B446S100757NW0

DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.

POLYTECHNIC RESOURCES INC

Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece Pulmonary function testing filter/mouthpiece
Primary Device IDB446S100757NW0
NIH Device Record Key8d3051b9-5a95-4c04-8c52-a0c59d7d709c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolytech Filter
Version Model NumberS100757NW
Company DUNS825021079
Company NamePOLYTECHNIC RESOURCES INC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter
Outer Diameter34.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB446S100757NW0 [Unit of Use]
HIBCCB446S100757NW1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZGSpirometer, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Polytech Filter]

B446TNN1031Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446TNN1021Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446TNN1011Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446SAMPLES9Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PUL9000N1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PUL9000K1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PUL9000E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PR772505MP1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PR7725051Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PR0224621Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PR0224541Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PMP757NW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PMP756NX1DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SI
B446PMP756EX1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT851E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT8511Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT830E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT8301Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT819E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446PFT8191Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5559100E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55591001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55581001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5557100E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55571001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5556100E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55561001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5554100E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55541001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55531001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5551100S1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P5551100E1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446P55511001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446FIL90001Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446FIL79581Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS780NW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS759WC1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS758NW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS758NNK1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS757NW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS757NKNW1DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SI
B446EBS757EW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS757EB1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756NX1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756NW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756NP1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756NG1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756NB1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756EX1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si
B446EBS756EW1Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for si

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