Duns Number:341625331
Device Description: The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring res The Clean Peak Flow Meter is an invasive, non-electrical medical device for monitoring respiratory conditions. The device is for measuring the Peak Expiratory Flow (PEF) or the maximum velocity of air expelled from the lungs. The children model is intended for patients from 6 years on up to 12 years.
Catalog Number
-
Brand Name
Clean Peak Flow Meter
Version/Model Number
Clean Peak Flow Meter - Children
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091412
Product Code
BZH
Product Code Name
Meter, Peak Flow, Spirometry
Public Device Record Key
febbaef9-f9a0-42ad-899b-2eafab2e3b78
Public Version Date
December 31, 2021
Public Version Number
5
DI Record Publish Date
March 01, 2017
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. | 32 |