Catalog Number

13063329

Brand Name

Spacelabs Healthcare

Version/Model Number

DATUM

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 12, 2019

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

K942799

Product Code

CAD

Product Code Name

VAPORIZER, ANESTHESIA, NON-HEATED

Public Device Record Key

af6c8c2f-eb43-48b7-bf4f-cf6df163e067

Public Version Date

July 12, 2019

Public Version Number

5

DI Record Publish Date

December 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-