Catalog Number

QB15016SGC

Brand Name

Halyard

Version/Model Number

43059

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K073187,K073187

Product Code

CAZ

Product Code Name

Anesthesia conduction kit

Public Device Record Key

654640dd-9465-4656-b86a-0c05e34befca

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

August 10, 2016

Package DI Number

30680651430596

Quantity per Package

5

Contains DI Package

10680651430592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS