Duns Number:058614483
Device Description: Portable SpO2 Patient Monitoring System, PM10N
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
PM10N
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141542,K141542
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
723988c8-a118-4cb6-850b-668598c93b98
Public Version Date
August 31, 2022
Public Version Number
8
DI Record Publish Date
September 27, 2016
Package DI Number
10884521208780
Quantity per Package
10
Contains DI Package
20884521208787
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |