Duns Number:830864406
Device Description: Adult Peak Flow Meter
Catalog Number
E5010-2
Brand Name
SpiroFlow
Version/Model Number
E5010
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 2020
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
-
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
K915059,K915059,K915059,K915059
Product Code
BZH
Product Code Name
Meter, Peak Flow, Spirometry
Public Device Record Key
e48c13de-94e5-40cc-b7a9-22db1357e023
Public Version Date
September 24, 2020
Public Version Number
4
DI Record Publish Date
October 11, 2016
Package DI Number
00855784004030
Quantity per Package
8
Contains DI Package
00855784004221
Package Discontinue Date
August 28, 2020
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |