Duns Number:008124539
Device Description: Pulse Oximeter
Catalog Number
-
Brand Name
Pulse Oximeter
Version/Model Number
36400
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)
-
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
d7aa9575-b6e3-4366-963e-bf474c4c2822
Public Version Date
December 30, 2021
Public Version Number
1
DI Record Publish Date
December 22, 2021
Package DI Number
00840117310179
Quantity per Package
10
Contains DI Package
00840117310162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master 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 |