Duns Number:118380146
Device Description: 226 cm (89") Appx 11.1 ml, 60 Drop Admin Set w/Easydrop Flow Controller, Pre-Pierced Port, 226 cm (89") Appx 11.1 ml, 60 Drop Admin Set w/Easydrop Flow Controller, Pre-Pierced Port, Rotating Luer
Catalog Number
0E5919260
Brand Name
ICU Medical
Version/Model Number
0E59-60
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
K964435,K964435
Product Code
FMG
Product Code Name
Stopcock, i.V. Set
Public Device Record Key
8262dd2a-fae2-4055-a9fd-4ae773e5ff1e
Public Version Date
August 11, 2021
Public Version Number
1
DI Record Publish Date
August 03, 2021
Package DI Number
10840619099371
Quantity per Package
50
Contains DI Package
00840619099374
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 |