Duns Number:825021079
Device Description: Disposable bacterial/virus filter for pulmonary function testing. This filter is intended Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.
Catalog Number
-
Brand Name
Polytech Filter
Version/Model Number
M100780EW
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
ecadfbe0-af20-40a5-88f4-c42470d6fae7
Public Version Date
March 02, 2021
Public Version Number
1
DI Record Publish Date
February 22, 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 |