Duns Number:544922461
Device Description: Spo2 extension cable
Catalog Number
-
Brand Name
Launch
Version/Model Number
SLZ106
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
463704cb-fc12-43cf-9c2f-da24544c397e
Public Version Date
May 18, 2020
Public Version Number
1
DI Record Publish Date
May 09, 2020
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 | 
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 62 |