AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Box 10 Ct.) - AN11 - Andersen Nasogastric Tube, Pediatric, 10 - ANDERSEN PRODUCTS, INC.

Duns Number:041867342

Device Description: AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Box 10 Ct.)

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More Product Details

Catalog Number

-

Brand Name

AN11 - Andersen Nasogastric Tube, Pediatric, 10 Fr. (Box 10 Ct.)

Version/Model Number

AN11.00

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K021493

Product Code Details

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Device Record Status

Public Device Record Key

642dbbab-7727-45a7-8d98-e662b17fcc33

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANDERSEN PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41