EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector - EndoVive Gastrostomy Tube, Right Angle, with - XERIDIEM MEDICAL DEVICES, INC.

Duns Number:183325125

Device Description: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 14FR

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More Product Details

Catalog Number

70-0053-114

Brand Name

EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector

Version/Model Number

M00509970

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K142075,K142075

Product Code Details

Product Code

PIF

Product Code Name

Gastrointestinal Tubes With Enteral Specific Connectors

Device Record Status

Public Device Record Key

2465f6d5-42b0-4431-b8a4-534b0262109b

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 03, 2016

Additional Identifiers

Package DI Number

00813939024012

Quantity per Package

5

Contains DI Package

00813939023732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box

"XERIDIEM MEDICAL DEVICES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 121