Catalog Number

-

Brand Name

Intercept i2 Oral Fluid Collection Device

Version/Model Number

3001-2661

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

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Public Device Record Key

98c43815-564d-48d3-bb40-d1ef4408baeb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 29, 2016

Package DI Number

10608337000914

Quantity per Package

50

Contains DI Package

00608337000917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton