Duns Number:080572190
Device Description: The Dagamma DP250 finger pulse oximeter is a lightweight, portable device used for measuri The Dagamma DP250 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2 and Perfusion Index
Catalog Number
-
Brand Name
Dagamma
Version/Model Number
Finger Pulse Oximeter DP250
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
DQA
Product Code Name
Oximeter
Public Device Record Key
f387ac1c-758c-446a-9c07-9325b457d950
Public Version Date
December 06, 2021
Public Version Number
3
DI Record Publish Date
May 28, 2020
Package DI Number
10628055787454
Quantity per Package
1
Contains DI Package
00628055787457
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Product Packaging
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |