Catalog Number

CI+1632-2C

Brand Name

NIPRO SAFELET CATH

Version/Model Number

CI+1632

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

c9042a00-f196-45e1-a316-7a4099a8c66c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

40383790006307

Quantity per Package

5

Contains DI Package

20383790006303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-