Duns Number:070556204
Device Description: Curaplex Select IV Admin Set, 15 Drop, 89 in, 1 LL Site, 1 PP Site, 6 in Ext Set w/Pinch C Curaplex Select IV Admin Set, 15 Drop, 89 in, 1 LL Site, 1 PP Site, 6 in Ext Set w/Pinch Clamp 50/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
15-10411
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
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
041f9601-cd7f-452a-adb9-f5c6ea3a4a5a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2016
Package DI Number
00815277023269
Quantity per Package
50
Contains DI Package
00815277023252
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |