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

Yes No

Clear

DUAL CHAMBER WARMING CABINET - B286DWC183064TG4BC1 Catalog Number : DWC183064T-G-4B-C

Device Description : Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelve Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper chamber door lockData loggerFoot levelersCelciusElectrical: 120V, 10 Amp, 50/60 Hz. .49kw/hr, 1678 btu/hr.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC183064TGMB1 Catalog Number : DWC183064T-G-MB

Device Description : Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelve Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper chamber door lockData loggerMobile BaseElectrical: 120V, 10 Amp, 50/60 Hz. .49kw/hr, 1678 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 - B286DWC183064TGNB1 Catalog Number : DWC183064T-G-NB

Device Description : Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelve Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper chamber door lockData loggerNo baseFoot levelersElectrical: 120V, 10 Amp, 50/60 Hz. .49kw/hr, 1678 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 - B286DWC183064TMB1 Catalog Number : DWC183064T-MB

Device Description : Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelve Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper chamber door lockData loggerMobile BaseElectrical: 120V, 10 Amp, 50/60 Hz. .49kw/hr, 1678 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 - B286DWC183064TNB1 Catalog Number : DWC183064T-NB

Device Description : Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelve Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper chamber door lockData loggerNo baseFoot levelersElectrical: 120V, 10 Amp, 50/60 Hz. .49kw/hr, 1678 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 FLUID/BLANKET WARMER - B286DWC183074E2B1 Catalog Number : DWC183074E-2B

Device Description : Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Cubic ft. storage.Lower chamber I.D. 26 “W x 17”D x 26”T 6.65 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves Stainless steel doorsAudible and visual over-temp alarm.Keyed temperature lockData loggerDual upper door lock2" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC183074E4B1 Catalog Number : DWC183074E-4B

Device Description : Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Cubic ft. storage.Lower chamber I.D. 26 “W x 17”D x 26”T 6.65 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves Stainless steel doorsAudible and visual over-temp alarm.Keyed temperature lockData loggerDual upper door lock4" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET/FLUID WARMER - B286DWC183074EG4B1 Catalog Number : DWC183074E-G-4B

Device Description : Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Cubic ft. storage.Lower chamber I.D. 26 “W x 17”D x 26”T 6.65 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves Glass doorsAudible and visual over-temp alarm.Keyed temperature lockData loggerDual upper door lock4" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC183074T4B1 Catalog Number : DWC183074T-4B

Device Description : DUAL CHAMBER WARMING CABINET30" X 20.218" X 74.924"355.79 LBS

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286DWC183074T4BR11 Catalog Number : DWC183074T-4B-R1

Device Description : Overall size 30”W x 18”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 15.25”T 17. Overall size 30”W x 18”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 15.25”T 17.2 Cubic ft. storage.Lower chamber I.D. 26 “W x 17”D x 34.5”T 11.93 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves Stainless steel doors. Audible and visual over-temp alarm.Data loggerDual upper door lock4" baseRecessed with no top/sides Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

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