Duns Number:070556204
Device Description: IV Catheter, ClearSafe Comfort, 20 ga x 1 in, Safety 50ea/bx 4bx/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
1612-84245
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
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
0bb4acfc-6c22-429d-8346-d7b532c4a674
Public Version Date
November 02, 2020
Public Version Number
4
DI Record Publish Date
December 16, 2016
Package DI Number
00815277023696
Quantity per Package
4
Contains DI Package
00815277023702
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 |