Duns Number:124987988
Device Description: Nexiva 18Gx1.25” Dual Port MaxZero Cue
Catalog Number
393559
Brand Name
BD Nexiva
Version/Model Number
393559
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
FOZ
Product Code Name
Catheter, intravascular, therapeutic, short-term less than 30 days
Public Device Record Key
c4d38df8-8f03-43cf-89e9-4bb1de06b33a
Public Version Date
November 15, 2021
Public Version Number
2
DI Record Publish Date
August 17, 2021
Package DI Number
20801741222478
Quantity per Package
4
Contains DI Package
10801741222471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BX
| 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 |