Catalog Number

-

Brand Name

NRFit

Version/Model Number

21-7600-24

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

K162219,K162219

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

90a2aba1-2a44-496a-8f3d-0f5b2db5c959

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2017

Package DI Number

30610586044001

Quantity per Package

12

Contains DI Package

10610586044007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX