Catalog Number

161

Brand Name

Dale Nasogastric Tube Holder

Version/Model Number

161

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

16fbcd20-ef2c-451f-8383-cd21adc3d019

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

August 29, 2018

Package DI Number

H84101612

Quantity per Package

50

Contains DI Package

H84101611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box