Catalog Number

59681

Brand Name

Halyard

Version/Model Number

59681

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

d369d43b-1e6e-4826-a75e-a6422ee8eb6e

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

30680651596810

Quantity per Package

24

Contains DI Package

10680651596816

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS