Duns Number:825021079
Device Description: DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED DISPOSABLE BACTERIAL/VIRAL FILTER FOR PULMONARY FUNCTION TESTING. THIS FILTER IS INTENDED FOR SINGLE PATIENT USE ONLY.
Catalog Number
-
Brand Name
Polytech Filter
Version/Model Number
S100757NW
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K042758,K042758
Product Code
BZG
Product Code Name
Spirometer, Diagnostic
Public Device Record Key
8d3051b9-5a95-4c04-8c52-a0c59d7d709c
Public Version Date
May 04, 2021
Public Version Number
1
DI Record Publish Date
April 26, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |