Medela - Silicone Enteral Feeding Tube - TwistLok - 40cm - FOOTPRINT MEDICAL, INC.

Duns Number:791238046

Device Description: Silicone Enteral Feeding Tube - TwistLok - 40cm by 6.5 French

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More Product Details

Catalog Number

-

Brand Name

Medela

Version/Model Number

ENSI4065

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

K090559,K090559,K090559

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

ba3f692f-bb0f-498c-b436-a5d0b73d4cab

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 16, 2017

Additional Identifiers

Package DI Number

10859950007372

Quantity per Package

10

Contains DI Package

00859950007375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"FOOTPRINT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 133