Duns Number:118380146
Device Description: 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, 0.2 30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/Integrated ChemoLock™ Port Drip Chamber, 0.2 Micron Filter, ChemoLock™ w/Red Cap, Bag Hanger
Catalog Number
CL3528T
Brand Name
ICU Medical
Version/Model Number
CL3528T
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
e7557f5f-4597-4205-9dbd-d5c6754fcdbb
Public Version Date
December 17, 2021
Public Version Number
1
DI Record Publish Date
December 09, 2021
Package DI Number
10887709120027
Quantity per Package
50
Contains DI Package
00887709120020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4887 |