FDA.report

Polytech Filter

Primary DI
B446100760WN1
Brand
Polytech Filter
Company
POLYTECHNIC RESOURCES INC
Model
100760WN
Device description
Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
Published
2016-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BZGSpirometer, Diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B446100760WN1PrimaryHIBCC0
B446100760WN0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Pulmonary function testing kitA collection of non-sterile devices intended to be used in conjunction with pulmonary function analysis equipment to perform a pulmonary function test. It may include a breathing mouthpiece, filter (intended to reduce contamination of parent device), and a nose clip. This is a single-use device.

Device Sizes

TypeValueUnit
Outer Diameter38.8Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
825021079
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
B446756W0POLYTECH FILTER756W2021-10-25
B446100759EN0Polytech Filter100759EN2021-08-23
B446M100780E20Polytech FilterM100780E22021-08-23
B446S100757NW0Polytech FilterS100757NW2021-04-26
B446100780EL0Polytech FilterM100780EL2021-02-22
B446M100780EW0Polytech FilterM100780EW2021-02-22
B446M100780W0Polytech FilterM100780W2021-02-22
B446N100756NKNS0Polytech FilterN100756NKNS2021-02-22
B446N100758NKNS0Polytech FilterN100758NKNS2021-02-22
B446S100756EW0Polytech FilterS100756EW2021-02-22
B446S100756NW0Polytech FilterS100756NW2021-02-22
B446S100757NKNW0Polytech FilterS100757NKNW2021-02-22
B446S100758EL0Polytech FilterS100758EL2021-02-22
B446S100758NK0Polytech FilterS100758NK2021-02-22
B446S100758NW0Polytech FilterS100758NW2021-02-22
B446S100759EW0Polytech FilterS100759EW2021-02-22
B446N100753S0Polytech NoseclipN100753S2020-12-18
B446N1007540Polytech MouthpieceN1007542020-07-03
B446757G1Polytech Filter757G2020-01-13
B446757ELMN1Polytech Filter757ELMN2018-11-28

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