Catalog Number

-

Brand Name

Heating tube set for insufflation, single use

Version/Model Number

Z0260

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153513,K153513

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

7968a1b7-ae9d-48e0-91ca-274fc38d1b6f

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 24, 2019

Package DI Number

04056702007386

Quantity per Package

10

Contains DI Package

04056702007379

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-