Duns Number:118380146
Device Description: 5.5" (14 cm) Appx 0.82 ml, Ext Set, Trifuse Smallbore w/3 Check Valves, 3 Clamps (Blue, Ye 5.5" (14 cm) Appx 0.82 ml, Ext Set, Trifuse Smallbore w/3 Check Valves, 3 Clamps (Blue, Yellow, White), Luer Lock
Catalog Number
B1816
Brand Name
ICU Medical
Version/Model Number
B1816
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
ac529aaa-48ec-496b-8375-ec38ea2db551
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
Package DI Number
10887709125701
Quantity per Package
50
Contains DI Package
00887709125704
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |