Catalog Number

INFOCAP-E

Brand Name

Infinity Low Volume Screw Cap Set with Enfit Connector

Version/Model Number

INFOCAP-E

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

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Public Device Record Key

de146a3f-b35e-4c3d-8e4e-9e341c95845b

Public Version Date

October 04, 2021

Public Version Number

1

DI Record Publish Date

September 24, 2021

Package DI Number

30814844001991

Quantity per Package

30

Contains DI Package

10814844001997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-