Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection - Entuit Gastrostomy BR Balloon Retention Feeding - XERIDIEM MEDICAL DEVICES, INC.

Duns Number:183325125

Device Description: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR

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More Product Details

Catalog Number

70-0060-116

Brand Name

Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

Version/Model Number

SBRD-16-ENF

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

K130611,K130611

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

e693f54b-3a2e-4785-b6d7-e8960276a8f7

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

10827002447827

Quantity per Package

10

Contains DI Package

00827002447820

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