FDA.reportPublic FDA data

Polytech Mouthpiece

Primary DI
B446N1007540
Brand
Polytech Mouthpiece
Company
POLYTECHNIC RESOURCES INC
Model
N100754
Device description
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.
Published
2020-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B446N1007541PrimaryHIBCC0
B446N1007540Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825021079
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B446756W1POLYTECH FILTER756W2021-10-25
B446756W0POLYTECH FILTER756W2021-10-25
B446100759EN1Polytech Filter100759EN2021-08-23
B446M100780E21Polytech FilterM100780E22021-08-23
B446100759EN0Polytech Filter100759EN2021-08-23
B446M100780E20Polytech FilterM100780E22021-08-23
B446S100757NW1Polytech FilterS100757NW2021-04-26
B446S100757NW0Polytech FilterS100757NW2021-04-26
B446M100780EL1Polytech FilterM100780EL2021-02-22
B446M100780EW1Polytech FilterM100780EW2021-02-22
B446M100780W1Polytech FilterM100780W2021-02-22
B446N100756NKNS1Polytech FilterN100756NKNS2021-02-22
B446N100758NKNS1Polytech FilterN100758NKNS2021-02-22
B446S100756EW1Polytech FilterS100756EW2021-02-22
B446S100756NW1Polytech FilterS100756NW2021-02-22
B446S100757NKNW1Polytech FilterS100757NKNW2021-02-22
B446S100758EL1Polytech FilterS100758EL2021-02-22
B446S100758NK1Polytech FilterS100758NK2021-02-22
B446S100758NW1Polytech FilterS100758NW2021-02-22
B446S100759EW1Polytech FilterS100759EW2021-02-22

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