Catalog Number

NC2-1

Brand Name

nfant® Coupling

Version/Model Number

1

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

K143507,K143507

Product Code

HCC

Product Code Name

Device, Biofeedback

Public Device Record Key

56342529-a7a8-4c77-9cf7-cb79c442508b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

00861410000222

Quantity per Package

25

Contains DI Package

00861410000239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-