Duns Number:010712461
Device Description: Curaplex Slct IV Admin Set, 15Dp,89in,Rlr Clmp,PP Ysite,Sr-Lk NdleFr Y, Attch Ext Set, 1/ Curaplex Slct IV Admin Set, 15Dp,89in,Rlr Clmp,PP Ysite,Sr-Lk NdleFr Y, Attch Ext Set, 1/EA 50EA/CS
Catalog Number
1712-60830
Brand Name
Curaplex
Version/Model Number
1712-60830
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
9927a8b3-26cf-4a55-bd9b-30948418e599
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2019
Package DI Number
00812277034554
Quantity per Package
50
Contains DI Package
00812277034493
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |