Catalog Number

-

Brand Name

Tube set for insufflation, single-use

Version/Model Number

Z1422-01

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

K030837,K030837

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

b9294ec0-5382-4ded-b400-d7363ef2cd8b

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 01, 2016

Package DI Number

04056702000066

Quantity per Package

10

Contains DI Package

04056702000059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-