Catalog Number

FHCSWC1824-TL-DEMO

Brand Name

COUNTER TOP BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T

Version/Model Number

FHCSWC1824-TL-DEMO

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

69135af8-e1c9-42cc-8fd0-8e51528e0042

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-