Duns Number:010712461
Device Description: Curaplex IV Admin St, 10Drp, 89in, Rll Clmp,PP YSite, SrLk Ndle Fr YSite, Atchd Ext Set,1 Curaplex IV Admin St, 10Drp, 89in, Rll Clmp,PP YSite, SrLk Ndle Fr YSite, Atchd Ext Set,1 EA 50EA per CS
Catalog Number
1712-10835
Brand Name
Curaplex
Version/Model Number
1712-10835
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
302e3e1b-7f41-4a3a-80cc-999db22b136e
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
July 01, 2019
Package DI Number
00812277034530
Quantity per Package
50
Contains DI Package
00812277034479
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 |