Duns Number:058614483
Device Description: GE CARESCAPE SpO2 - Nellcor. For use with GE Patient Monitors.
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
PMC10GE360N
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
K172482,K172482
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
7cddd949-7716-467b-a5a6-c554d902fb0c
Public Version Date
September 15, 2021
Public Version Number
4
DI Record Publish Date
March 22, 2018
Package DI Number
20884521705347
Quantity per Package
20
Contains DI Package
10884521705340
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 |