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 WARMING CABINET - B286DWC243074TG4BC1 Catalog Number : DWC243074T-G-4B-C

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 loggerCelciusElectrical: 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 - B286DWC243074TG4BSB1 Catalog Number : DWC243074T-G-4B-SB

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 shelves.Upper 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 doors. Audible and visual over-temp alarm. Keyed temperature lockUpper chamber door lockData loggerSeismic brace4" 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 - B286DWC243074TGLH4B1 Catalog Number : DWC243074T-G-LH-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 doorsLeft hand hingeAudible 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 - B286DWC243074TGMB220UK1 Catalog Number : DWC243074T-G-MB-220UK

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 loggerMobile BaseElectrical: 220V, 6 Amp, 60 Hz. United Kingdom PlugUL/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 - B286DWC243074TGMBSB1 Catalog Number : DWC243074T-G-MB-SB

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 shelves.Upper 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 doors. Audible and visual over-temp alarm. Keyed temperature lockUpper chamber door lockData loggerSeismic braceMobile 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 - B286DWC243074TGP4B1 Catalog Number : DWC243074T-G-P-4B

Device Description : DUAL CHAMBER WARMING CABINET

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET, TSD - B286DWC243074TGTSELMB1 Catalog Number : DWC243074T-G-TS-EL-MB

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 shelves.Upper 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 Mobile baseKeyed temperature lockGlass doors.Touch screenElectronic lock Audible and visual over-temp alarm. Digital controlElectrical: 120V, 12 Amp, 50/60 Hz .75kw/hr, 2557 btu/hrUL/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 - B286DWC243074TLH4B1 Catalog Number : DWC243074T-LH-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 Stainless steel doorsAudible and visual over-temp alarmTemperature Lock Foot levelersDoor lock on upper chamberData loggerLeft Hand hinge4" baseElectrical: 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 - B286DWC243074TLHMB1 Catalog Number : DWC243074T-LH-MB

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 shelves.Upper 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. Stainless steel doors. Audible and visual over-temp alarm. Data LoggerUpper Chamber LockTemperature LockLeft hand hinge Mobile 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 - B286DWC243074TMB1 Catalog Number : DWC243074T-MB

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 shelves.Upper 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. Stainless steel doors. Audible and visual over-temp alarm. Data LoggerUpper Chamber LockTemperature Lock Mobile 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

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