Duns Number:058027090
Device Description: 10868750000247 = basePkg;20868750000244 = higherPkg1 - contains 100 of the base package Pr 10868750000247 = basePkg;20868750000244 = higherPkg1 - contains 100 of the base package Primary DI inside it;30868750000241 = higherPkg2 - contains 4 of the higherPkg1 inside it.Disposable bacterial/viral filter for pulmonary function testing - white
Catalog Number
7700PFT
Brand Name
Pulmonary Filtration Technologies
Version/Model Number
7700PFT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 17, 2019
Issuing Agency
In GS1
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
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
62549ff0-3082-4f8e-969c-9696ca12b05f
Public Version Date
November 06, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |