Pulmonary Filtration Technologies - 10868750000223 = basePkg;20868750000220 = - WHITE CARDIOPULMONARY, INC.

Duns Number:058027090

Device Description: 10868750000223 = basePkg;20868750000220 = higherPkg1 - contains 100 of the base package Pr 10868750000223 = basePkg;20868750000220 = higherPkg1 - contains 100 of the base package Primary DI inside it;30868750000227 = higherPkg2 - contains 4 of the higherPkg1 inside it.Disposable bacterial/viral filter for pulmonary function testing - multi

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More Product Details

Catalog Number

7500PFT

Brand Name

Pulmonary Filtration Technologies

Version/Model Number

7500PFT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 05, 2019

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Device Record Status

Public Device Record Key

e3e3727f-fa52-42a5-b6c1-2c2b667d3847

Public Version Date

November 06, 2019

Public Version Number

3

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WHITE CARDIOPULMONARY, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4