Duns Number:058614483
Device Description: Adult SpO2 Sensor, Low profile connector. For use with Vital Sync Wearable SpO2 Patient Mo Adult SpO2 Sensor, Low profile connector. For use with Vital Sync Wearable SpO2 Patient Monitor
Catalog Number
-
Brand Name
Nellcor
Version/Model Number
MAXNW
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
Yes
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
K012891,K012891
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
335c42cb-3f12-42da-a973-256f5b41d814
Public Version Date
November 10, 2021
Public Version Number
4
DI Record Publish Date
July 04, 2021
Package DI Number
20884521546803
Quantity per Package
24
Contains DI Package
10884521546806
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 |