FDA.report

Polytech Filter

Primary DI
B446100757NT1
Brand
Polytech Filter
Company
POLYTECHNIC RESOURCES INC
Model
100757NT
Device description
Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
Published
2016-11-15
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
B446100757NT1PrimaryHIBCC0
B446100757NT0Unit of UseHIBCC0

GMDN Terms

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.

Device Sizes

TypeValueUnit
Outer Diameter34.3Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
825021079
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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

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B446N100753S0Polytech NoseclipN100753S2020-12-18
B446N1007540Polytech MouthpieceN1007542020-07-03
B446757G1Polytech Filter757G2020-01-13
B446757ELMN1Polytech Filter757ELMN2018-11-28

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