Duns Number:124987988
Device Description: NEXIVA 18 GA X 1.25IN SP WITH MAXZERO
Catalog Number
383559
Brand Name
BD Nexiva
Version/Model Number
383559
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
-
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
K170336,K170336,K170336
Product Code
FOZ
Product Code Name
Catheter,intravascular,therapeutic,short-term less than 30 days
Public Device Record Key
5438cb8a-dcd8-42be-ad87-285ee03eccf6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2017
Package DI Number
50382903835596
Quantity per Package
4
Contains DI Package
30382903835592
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 | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |