Duns Number:118380146
Device Description: Oncology Kit w/5" (13 cm) Appx 1.8 ml, Transfer Set w/ChemoLock™ w/Red Cap, Vented Cap; Ch Oncology Kit w/5" (13 cm) Appx 1.8 ml, Transfer Set w/ChemoLock™ w/Red Cap, Vented Cap; ChemoLock™ Port Vented Bag Spike; Spiros™ w/Red Cap
Catalog Number
CL4116T
Brand Name
ICU Medical
Version/Model Number
CL4116T
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
K131549,K131549
Product Code
ONB
Product Code Name
Closed antineoplastic and hazardous drug reconstitution and transfer system
Public Device Record Key
0e359502-a3dd-443a-ad5d-b49614f2814e
Public Version Date
August 04, 2021
Public Version Number
1
DI Record Publish Date
July 27, 2021
Package DI Number
10887709120003
Quantity per Package
50
Contains DI Package
00887709120006
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 |