Duns Number:118380146
Device Description: Add On Safeset™ Reservoir Kit w/Needleless Valve
Catalog Number
46200-30
Brand Name
ICU Medical
Version/Model Number
46200-30
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
K932188,K932188
Product Code
DXN
Product Code Name
System, measurement, blood-pressure, non-invasive
Public Device Record Key
804026bf-9365-4109-bd52-c2268dbb5b64
Public Version Date
November 03, 2021
Public Version Number
1
DI Record Publish Date
October 26, 2021
Package DI Number
10887709078410
Quantity per Package
20
Contains DI Package
00887709078413
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4887 |