Catalog Number

33101

Brand Name

Halyard

Version/Model Number

33101

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)

-

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

252ac92b-7336-4fbf-b1d2-f7ec803ca9a9

Public Version Date

November 24, 2020

Public Version Number

1

DI Record Publish Date

November 16, 2020

Package DI Number

30680651331015

Quantity per Package

2

Contains DI Package

20680651331018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS