Catalog Number

R9900090

Brand Name

Hang&Go HT Basic

Version/Model Number

000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2020

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

K120026

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Public Device Record Key

55012470-1157-4913-b11d-031fd8e26991

Public Version Date

July 24, 2020

Public Version Number

5

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-