Duns Number:008124539
Device Description: Resp-O2 Peak Flow Meters Full Range 50-800 l/min
Catalog Number
-
Brand Name
Resp-O2 Peak Flow Meter
Version/Model Number
36111
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K172804,K172804
Product Code
BZH
Product Code Name
Meter, Peak Flow, Spirometry
Public Device Record Key
e17a49f7-b421-45aa-8b61-78aeb811c950
Public Version Date
April 30, 2021
Public Version Number
1
DI Record Publish Date
April 22, 2021
Package DI Number
00840117318793
Quantity per Package
10
Contains DI Package
00840117319042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |