Catalog Number

-

Brand Name

CarbonAid CO2 Diffuser

Version/Model Number

2800

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

K112975,K112975,K112975

Product Code

HIF

Product Code Name

Insufflator, Laparoscopic

Public Device Record Key

c6174f63-c2de-4385-b1e6-e178525407c5

Public Version Date

September 20, 2021

Public Version Number

4

DI Record Publish Date

August 24, 2016

Package DI Number

27340026100023

Quantity per Package

3

Contains DI Package

17340026100026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-