Catalog Number

TEMH015

Brand Name

Halyard

Version/Model Number

TEMH015_0008

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OGD

Product Code Name

Custom anesthesia tray

Public Device Record Key

c9ceff0c-452b-4d09-b014-e1cb83eaa477

Public Version Date

June 06, 2022

Public Version Number

1

DI Record Publish Date

May 27, 2022

Package DI Number

20809160371913

Quantity per Package

20

Contains DI Package

10809160371916

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-