Catalog Number

-

Brand Name

HIGH-FLOW TUBE SET

Version/Model Number

0620050100

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"

-

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

K170784,K170784

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

e6bc85cb-585e-4824-a14d-8628001d6cb8

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 24, 2017

Package DI Number

04056702001537

Quantity per Package

10

Contains DI Package

04056702001520

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-