Duns Number:878291677
Device Description: Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expirat Safey Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment.The device is designed for children greater than five years of age, adolescent and adult subjects.
Catalog Number
-
Brand Name
Safey Peak Flow Meter
Version/Model Number
165253
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
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
K200832
Product Code
BZH
Product Code Name
Meter, Peak Flow, Spirometry
Public Device Record Key
8fe6324e-26da-4eb0-b057-2c9952e69ff5
Public Version Date
February 14, 2022
Public Version Number
1
DI Record Publish Date
February 04, 2022
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. | 2 |