FDA.reportPublic FDA data

Polytech Filter

Primary DI
B446M100780EL1
Brand
Polytech Filter
Company
POLYTECHNIC RESOURCES INC
Model
M100780EL
Device description
Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
Published
2021-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042758000POLYTECH PULMONARY FUNCTION FILTERPolytechnic Resources, Inc.2005-08-29BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B446M100780EL1PrimaryHIBCC0
B446100780EL0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular graft extraluminal mesh-sleeve, coronaryA non-bioabsorbable implantable device intended to be used for the extraluminal (external) support of a coronary artery bypass graft (CABG) [e.g., saphenous vein graft]. It is a tubular, metal [e.g., cobalt-chrome (Co-Cr)] mesh intended to improve the characteristics of the vascular graft (e.g., luminal uniformity, flow capability, luminal strength/stability, diameter matching) and reduce the risk of graft failure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter34.3Millimeter

Regulatory Flags#

DUNS number
825021079
Device count
100
Serial number
true
No natural rubber latex
true

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
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
S100758NKNW1Polytech FilterS100758NKNW2021-02-22

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Primary DI, Brand, Company table
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