Catalog Number

25-000009-49

Brand Name

Biosensors Central Venous Catheter Kit

Version/Model Number

CVR-501-16

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

128d4dba-1b0f-414f-8990-fc34a7bdce2f

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

78888893011102

Quantity per Package

8

Contains DI Package

28888893011107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CTN