Catalog Number

AN1004.00

Brand Name

EOGas 4 Refill Kit

Version/Model Number

AN1004.00

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150646

Product Code

FLF

Product Code Name

Sterilizer, Ethylene-Oxide Gas

Public Device Record Key

b0811fb5-9ea5-4a39-8e6c-3b99be5ccbba

Public Version Date

October 02, 2018

Public Version Number

1

DI Record Publish Date

September 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-