Duns Number:612746933
Catalog Number
-
Brand Name
Curlin Administration Set
Version/Model Number
340-4177
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"
-
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
-
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
69e3cba1-6b5e-4909-8f07-3d0a50ed2a09
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 22, 2016
Package DI Number
38148440000679
Quantity per Package
20
Contains DI Package
18148440000675
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 106 |