Catalog Number

R9900117

Brand Name

Hang&Go PAC

Version/Model Number

002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 10, 2022

Issuing Agency

In HIBCC

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

-

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

-

FDA Premarket Submission

K161613

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

4d28fb91-696d-48a6-bb0b-3efbaaa12885

Public Version Date

June 22, 2022

Public Version Number

2

DI Record Publish Date

February 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-