Duns Number:015510540
Device Description: 1.9Fr x 8cm Single Lumen Polyurethane EPIV with Stylet (Catheter Only)
Catalog Number
1946-1608
Brand Name
NeoMagic
Version/Model Number
1946-1608
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
K983916,K983916
Product Code
FOZ
Product Code Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Public Device Record Key
a55cb9fc-2f78-46df-a3ca-3e0c10aa62f1
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 11, 2022
Package DI Number
B339194616085
Quantity per Package
20
Contains DI Package
B339194616080
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |