Duns Number:006959555
Device Description: Meijer Economy Pulse Oximeter
Catalog Number
74-50K
Brand Name
Meijer
Version/Model Number
74-50K
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
d15cac7b-3220-4c7b-99b5-ea718e8e106c
Public Version Date
November 10, 2021
Public Version Number
3
DI Record Publish Date
September 15, 2016
Package DI Number
30708820268792
Quantity per Package
4
Contains DI Package
00708820268791
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 45 |
U | Unclassified | 1 |