Catalog Number

460604E

Brand Name

Argyle

Version/Model Number

460604E

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

0c1addd8-69e9-49ed-9262-97aed947208c

Public Version Date

November 16, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521547206

Quantity per Package

50

Contains DI Package

10884521547209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE