Ameritus - 8fr 40cm dual port feeding tube - KENTEC MEDICAL, INC.

Duns Number:066175613

Device Description: 8fr 40cm dual port feeding tube

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More Product Details

Catalog Number

AEG-Y80P-40

Brand Name

Ameritus

Version/Model Number

AEG-Y80P-40

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

K100526,K100526,K100526

Product Code Details

Product Code

FPD

Product Code Name

Tube, Feeding

Device Record Status

Public Device Record Key

11816118-8b47-4aa6-a6a4-bed786cdfa55

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2016

Additional Identifiers

Package DI Number

30817522012203

Quantity per Package

200

Contains DI Package

10817522012209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"KENTEC MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 44