Duns Number:070556204
Device Description: Curaplex Ext Set, 8 in, Removable Luer Locking Site, Pinch Clamp, Spin Lock Connection
Catalog Number
05-00811NEG
Brand Name
Curaplex
Version/Model Number
05-00811NEG
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
LHI
Product Code Name
Set, i.V. Fluid transfer
Public Device Record Key
156f549b-e561-4afd-8338-7b0e7bf8da92
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 18, 2017
Package DI Number
00817617023915
Quantity per Package
100
Contains DI Package
00817617023854
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |