DUAL CHAMBER WARMING CABINET - Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. - M.A.C. MEDICAL INC.

Duns Number:188660844

Device Description: Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpper Chamber Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storageAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage Accuracy +/- 3 degrees F Digital control Glass doorsAudible and visual over-temp alarmTemperature Lock Foot levelersDoor lock on upper chamberData loggerCelciusElectrical: 120V, 12 Amp, 50/60 Hz .75kw/hr, 2557 btu/hr UL/CUL listedFDA Registered

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More Product Details

Catalog Number

DWC243074T-G-4B-C

Brand Name

DUAL CHAMBER WARMING CABINET

Version/Model Number

DWC243074T-G-4B-C

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

3d9c86dd-1aba-43ea-88b3-44a33d16810d

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