Catalog Number

-

Brand Name

Infinity Low Volume Enteral Screw Cap with EnFit Connector

Version/Model Number

INFOCAP-A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 27, 2021

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

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

97f9d786-b491-43a7-a855-d38b89221726

Public Version Date

August 16, 2021

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

38148440000280

Quantity per Package

30

Contains DI Package

18148440000286

Package Discontinue Date

June 27, 2021

Package Status

Not in Commercial Distribution

Package Type

-