Catalog Number

FHCDWC36-18-TL-G-LH-220

Brand Name

DUAL CHAMBER BLANKET/FLUID WARMING CABINET Overall Size 30”W x 20.5”D x 74.5”T

Version/Model Number

FHCDWC36-18-TL-G-LH-220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080609

Product Code

LHC

Product Code Name

Warmer, Irrigation Solution

Public Device Record Key

f55f1f36-1e38-4a17-b3c1-1b31f0201303

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-