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) (8) Stretcher, Wheeled (FPO) (2)

Premarket Exempt

No Yes

Clear

5TH WHEEL STRETCHER WITH KNEE GATCH - B286FHC720031KNEE1 Catalog Number : FHC7200-31-KNEE

Device Description : 5TH WHEEL STRETCHER WITH KNEE GATCH

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

5TH WHEEL EYE STRETCHER - B286FHC7200EYE1 Catalog Number : FHC7200-EYE

Device Description : 5TH WHEEL EYE STRETCHER

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC21824TLG2201 Catalog Number : FHCDWC24-1824-TL-G-LH-220

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. 3 Adjustable shelves. Glass doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220V Left HandFoot levelers.

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET / FLUID WARMER - B286FHCDWC241824TL1 Catalog Number : FHCDWC24-1824-TL

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC241824TL2201 Catalog Number : FHCDWC24-1824-TL-220

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220V

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER WARMING CABINET - B286FHCDWC241824TLD1 Catalog Number : FHCDWC24-1824-TL-D

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.6 Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Data LoggerAudible and visual over-temp alarm. 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 Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC241824TLG1 Catalog Number : FHCDWC24-1824-TL-G

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Glass doors. Audible and visual over-temp alarm. 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 Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC241824TLG2201 Catalog Number : FHCDWC24-1824-TL-G-220

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Glass doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220V

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC241824TLL1 Catalog Number : FHCDWC24-1824-TL-LH

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. 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. Left Hand Foot levelers

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 74.5”T - B286FHCDWC241824TLL2201 Catalog Number : FHCDWC24-1824-TL-LH-220

Device Description : Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2. Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage.Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220V Left HandFoot levelers

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

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