Catalog Number

-

Brand Name

NIPRO SAFETOUCH IV CATHETER

Version/Model Number

NI-CSF2050PWET

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"

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

-

Product Code

FOZ

Product Code Name

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Public Device Record Key

c08fca28-bd83-4ebc-8ecf-478197f6b4ab

Public Version Date

October 09, 2019

Public Version Number

1

DI Record Publish Date

October 01, 2019

Package DI Number

40383790009650

Quantity per Package

40

Contains DI Package

10383790009659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE