Duns Number:780421038
Device Description: LNCS-II rainbow DCIP 8 lambda SpHb 400 spot checks Pediatric/Slender digit Pulse Oximeter LNCS-II rainbow DCIP 8 lambda SpHb 400 spot checks Pediatric/Slender digit Pulse Oximeter Reusable Sensor
Catalog Number
-
Brand Name
LNCS-II rainbow
Version/Model Number
4062
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
-
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
-
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
289e370d-f474-4887-9033-4e82f8108848
Public Version Date
October 15, 2021
Public Version Number
1
DI Record Publish Date
October 07, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |