Vaxcel - Vaxcel Titanium Standard Port with PASV Valve and - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: Vaxcel Titanium Standard Port with PASV Valve and 8F x 63cm Silicone Catheter

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Vaxcel

Version/Model Number

45364

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 02, 2021

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

a85509bc-b865-4357-80f1-0624cea358fd

Public Version Date

November 04, 2021

Public Version Number

3

DI Record Publish Date

September 14, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NAVILYST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71
2 A medical device with a moderate to high risk that requires special controls. 1641