Duns Number:175899459
Device Description: ADHESIVE SENSOR LNCS NEO WITH 9-PIN CONNECTOR
Catalog Number
MAS2329-9
Brand Name
NA
Version/Model Number
MAS2329-9
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"
Yes
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
K102560,K102560
Product Code
NLF
Product Code Name
OXIMETER, REPROCESSED
Public Device Record Key
be797f7e-f3b5-43ec-b5ab-c54677732add
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 22, 2016
Package DI Number
20888551042441
Quantity per Package
24
Contains DI Package
10888551042444
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2763 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1372 |
| U | Unclassified | 20 |