Catalog Number

-

Brand Name

Standard Bougie Handpump

Version/Model Number

SBHP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K212728,K212728

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

338b5d9f-d03b-4de0-af61-bb35cf8d98af

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Package DI Number

10851677007116

Quantity per Package

6

Contains DI Package

00851677007119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-