Duns Number:751908968
Device Description: myMDI Finger Pulse Oximeter is a non-invasive device used to measure oxygen saturation and myMDI Finger Pulse Oximeter is a non-invasive device used to measure oxygen saturation and pulse rate via the finger.
Catalog Number
-
Brand Name
myMDI Finger Pulse Oximeter
Version/Model Number
PO-FPO-US
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"
-
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
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
a3b5705e-ad52-4667-a173-0280479f94de
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 13, 2017
Package DI Number
10842135100050
Quantity per Package
250
Contains DI Package
00842135100053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |