Duns Number:058027090
Device Description: 10868750000216 = basePkg;20868750000213 = higherPkg1 - contains 100 of the base package Pr 10868750000216 = basePkg;20868750000213 = higherPkg1 - contains 100 of the base package Primary DI inside it;30868750000210 = higherPkg2 - contains 4 of the higherPkg1 inside it.Disposable bacterial/viral filter for pulmonary function testing - green
Catalog Number
7400PFT
Brand Name
Pulmonary Filtration Technologies
Version/Model Number
7400PFT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 27, 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
2e3c8b0e-87f3-4f49-9240-06eccefab73f
Public Version Date
December 05, 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 |