Duns Number:174959692
Device Description: Power Supply for use with Model 7500
Catalog Number
-
Brand Name
Nonin
Version/Model Number
7500PS
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)
-
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
1af85d67-b84f-4366-9f92-5f292af83ab7
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
00849686070187
Quantity per Package
1
Contains DI Package
00833166007558
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 130 |