Duns Number:078497467
Device Description: Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart ra Pulse Oximeter for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Catalog Number
453.76
Brand Name
Beurer
Version/Model Number
PO50
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
OCH
Product Code Name
Oximeter, Infrared, Sporting, Aviation
Public Device Record Key
5fd72cb6-6251-46f6-8a1d-6840d8620c73
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
May 25, 2020
Package DI Number
10850018808009
Quantity per Package
200
Contains DI Package
00850018808002
Package Discontinue Date
November 16, 2020
Package Status
Not in Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |