Duns Number:070556204
Device Description: IV Start Kit, incl Tegaderm, Wipe, 5cc Saline Syringe, 2x2 sponge, LF Tourniquet, Ext Set IV Start Kit, incl Tegaderm, Wipe, 5cc Saline Syringe, 2x2 sponge, LF Tourniquet, Ext Set 50/cs
Catalog Number
1840-01364-A
Brand Name
Curaplex
Version/Model Number
1840-01364-A
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
LRS
Product Code Name
I.V. start kit
Public Device Record Key
eae71bed-01b0-4165-b530-9aa4baef5710
Public Version Date
December 11, 2019
Public Version Number
3
DI Record Publish Date
October 13, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |