Catalog Number

-

Brand Name

TEC 7

Version/Model Number

VAP SEV 8% EASY-FIL ES LATIN AMERICA

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

-

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

K012924

Product Code

CAD

Product Code Name

VAPORIZER, ANESTHESIA, NON-HEATED

Public Device Record Key

abc3e093-8ac6-4ee8-8d4e-fd9e32e33dd0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-