NutraGlide Nasal Feeding Tube - 10FR x 90cm NutraGlide Nasal Feeding Tube with - APPLIED MEDICAL TECHNOLOGY, INC.

Duns Number:038101861

Device Description: 10FR x 90cm NutraGlide Nasal Feeding Tube with ENFit® (Sterile, Pouched)

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More Product Details

Catalog Number

ESNFT-10090-N-I

Brand Name

NutraGlide Nasal Feeding Tube

Version/Model Number

ESNFT-10090-N-I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K202539,K202539

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

259d4115-ddcd-44a0-a7b4-8e059b7941bb

Public Version Date

March 09, 2021

Public Version Number

1

DI Record Publish Date

March 01, 2021

Additional Identifiers

Package DI Number

00842071128005

Quantity per Package

10

Contains DI Package

00842071127367

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box (SNFT-10090-N-I)

"APPLIED MEDICAL TECHNOLOGY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 1325