M.A.C. MEDICAL INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Warmer, Irrigation Solution (LHC) (10)

Premarket Exempt

No Yes

Clear

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC243074EGLHNB1 Catalog Number : DWC243074E-G-LH-NB-R1

Device Description : Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage4 Adjustable shelve 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

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC243074EGMB1 Catalog Number : DWC243074E-G-MB

Device Description : Overall size 30”W x 26.5”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T Overall size 30”W x 26.5”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage.Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Digital control. 4 Adjustable shelves. Full view glass doors. Audible and visual over-temp alarm.Keyed temperature lock for each chamber, Door lock upper chamber.Accuracy +/- 2 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .69kw/hr, 2356 btu/hr. UL/CUL listed. T0087 Mobile Base included PREVIOUS WARMER DWC36-TL-G-MB

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC243074EGMB2201 Catalog Number : DWC243074E-G-MB-220

Device Description : Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.6 Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage.Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Digital control. 4 Adjustable shelves. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper Chamber door lock, Data loggerAccuracy +/- 2 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 220V UL/CUL listed.Mobile Base

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074T4B1 Catalog Number : DWC243074T-4B

Device Description : Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpp 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 (upper chamber)Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storageAccuracy +/- 3 degrees F (lower chamber)Digital control Stainless steel doors Audible and visual over-temp alarmTemperature Lock Data LoggerLocking upper chamberFoot levelersElectrical: 120V, 12 Amp, 50/60 Hz.75kw/hr, 2557 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074T4B2201 Catalog Number : DWC243074T-4B-220

Device Description : Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shel Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shelvesUpper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storageAccuracy +/- 1 degrees F (upper chamber)Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Accuracy +/- 3 degrees F (lower chamber)Keyed temperature lockStainless steel doors. Audible and visual over-temp alarm. Digital ControlKeyed temperature lockUpper chamber door lockData logger4" baseFoot levelersElectrical: 220V, 6 Amp, 60 Hz. UL/CUL listed.FDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074T4BC1 Catalog Number : DWC243074T-4B-C

Device Description : Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shel Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shelvesUpper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storageLower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. CelciusDigital control. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature Lock Data loggerUpper Chamber door lockFoot levelers4" baseElectrical: 120V, 12 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.FDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074T4BLDL1 Catalog Number : DWC243074T-4B-LDL

Device Description : Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpp 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 (upper chamber)Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storageAccuracy +/- 3 degrees F (lower chamber)Digital control Stainless steel doors Audible and visual over-temp alarmTemperature Lock Data LoggerLocking upper/lower chamberFoot levelersElectrical: 120V, 12 Amp, 50/60 Hz.75kw/hr, 2557 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074T4BR11 Catalog Number : DWC243074T-4B-R1

Device Description : Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpp 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 (upper chamber)Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storageAccuracy +/- 3 degrees F (lower chamber)Digital control Stainless steel doors Audible and visual over-temp alarmTemperature Lock Data LoggerLocking upper chamberFoot levelersRecessed no sides or topElectrical: 120V, 12 Amp, 50/60 Hz.75kw/hr, 2557 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074TG4B1 Catalog Number : DWC243074T-G-4B

Device Description : Overall size 30”W x 26.5”D x 74.5”T17.2 Cubic ft. storage3 Adjustable shelvesUpp 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 loggerElectrical: 120V, 12 Amp, 50/60 Hz .75kw/hr, 2557 btu/hr UL/CUL listedFDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC243074TG4B2201 Catalog Number : DWC243074T-G-4B-220

Device Description : Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shel Overall size 30”W x 26.5”D x 74.5”T. 17.2 Cubic ft. storage. 3 Adjustable shelvesUpper Chamber I.D. 26”W x 23”D x 15.25”T 5.27 Cubic ft. storageAccuracy +/- 1 degrees F (upper chamber)Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Accuracy +/- 3 degrees F (lower chamber)Keyed temperature lockGlass doors. Audible and visual over-temp alarm. Digital ControlKeyed temperature lockUpper chamber door lockData logger4" baseFoot levelersElectrical: 220V, 6 Amp, 60 Hz. UL/CUL listed.FDA Registered

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

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