DUAL CHAMBER BLANKET/FLUID WARMER - Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic - M.A.C. MEDICAL INC.

Duns Number:188660844

Device Description: Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage4 Adjustable shelves. Upper Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Recessed No top/sidesDigital control. Glass doors. Left hand hingeAudible and visual over-temp alarm. Keyed temperature lock for each chamber Upper door lockData loggerNo baseElectrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr. UL/CUL listedFDA Registered

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More Product Details

Catalog Number

DWC243074E-G-LH-NB-R1

Brand Name

DUAL CHAMBER BLANKET/FLUID WARMER

Version/Model Number

DWC243074E-G-LH-NB-R1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

LHC

Product Code Name

Warmer, Irrigation Solution

Device Record Status

Public Device Record Key

d751d88f-8392-41f9-953c-153360786e15

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"M.A.C. MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 456
2 A medical device with a moderate to high risk that requires special controls. 32