NeoMed NeoConnect Enteral Extension Sets - 40" (102cm) PVC Enteral Extension Set with ENFit - NEOMED, INC.

Duns Number:799772079

Device Description: 40" (102cm) PVC Enteral Extension Set with ENFit Connector, Large Bore, Purple

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More Product Details

Catalog Number

PEXT-40BNC

Brand Name

NeoMed NeoConnect Enteral Extension Sets

Version/Model Number

PEXT-40BNC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

9e993c32-e0ab-4788-a09a-321ec0f26839

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

20817584013005

Quantity per Package

8

Contains DI Package

10817584013008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"NEOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 183