Catalog Number

2083518

Brand Name

Hillrom powered by Augustine Surgical HD

Version/Model Number

2083518

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

-

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

K112488

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

578431a0-15cd-4767-88d1-b5ae49f0d58b

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-