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

Stretcher, Wheeled (FPO) (8) Warmer, Irrigation Solution (LHC) (2)

Premarket Exempt

No Yes

Clear

DUAL CHAMBER WARMING CABINET,TSD - B286DWC243074TTSG4B1 Catalog Number : DWC243074T-TS-G-4B

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)Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature Lock Foot levelersTouch ScreenUpper Door Lock4" BaseData LoggerElectrical: 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 WARMNG CABINET - B286DWC243074TTSGMB1 Catalog Number : DWC243074T-TS-G-MB

Device Description : DUAL CHAMBER WARMNG CABINET

Device Class : 1

Duns Number: 188660844

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

PERSONAL TRANSPORT STRETCHER (FHC) - B286FHC71001 Catalog Number : FHC7100

Device Description : MOBILECARE STRETCHER WITH PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 2 MOBILECARE STRETCHER WITH PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 23" TO 36". PEDALS LOCATED ON EITHER SIDE. +/- 18 DEGREE TRENDELENBURG AND REVERSE TRENDELEBURG, ADJUSTMENT PEDALS ON EITHER SIDE. FOLD FORWARD SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDALS LOCATED ON ALL 4 CORNERS. REMOVABLE 2 HOOK I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB.

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

FHC - PERSONAL TRANSPORT STRETCHER W/(OVERSIZED BED SURFACE 29" WIDE) - B286FHC7100291 Catalog Number : FHC7100-29

Device Description : MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. CLEARLY MARKED HEIGHT ADJU MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. CLEARLY MARKED HEIGHT ADJUST PEDALS ON BOTH SIDES WITH RANGE OF 23" TO 36". TRENDELENBURG AND REVERSE TRENDELEBURG ADJUSTMENT PEDALS ON BOTH SIDES. FOLD DOWN SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB.

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

COMPLETE EYE STRETCHER - B286FHC7100EYE1 Catalog Number : FHC7100-EYE

Device Description : COMPLETE EYE STRETCHER

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

PERSONAL TRANSPORT STRETCHER W ITH HEAD REST - B286FHC7100EYE11 Catalog Number : FHC7100-EYE1

Device Description : EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH S EYE MOBILE-CARE STRETCHER WITH CLEARLY MARKED HEIGHT ADJUSTMENT PEDALS ON BOTH SIDES FROM 23"TO 36" HIGH. TRENDELEBURG AND REVERSE TRENDELENBURG ADJUSTMENT PEDALS ON BOTH SIDES. CRANK BACKREST AND KNEE GATCH. DUAL ARTICULATION TAPERED HEADPIECE. FOLD DOWN SIDE RAILS. BUILT IN OXGEN CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" MATTRESS INCLUDED. PATIENT SURFACE 88" X 26" WITH 550 LB CAPACITY.

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

STRETCHER WITH KNEE GATCH - B286FHC7100KNEE1 Catalog Number : FHC7100-KNEE

Device Description : MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJU MOBILECARE STRETCHER WITH KNEE GATCH. PNEUMATIC FOWLER ADJUSTMENT. HEIGHT ADJUST RANGE OF 23" TO 36". PEDALS LOCATED ON EITHER SIDE. +/- 18 DEGREE TRENDELENBURG AND REVERSE TRENDELEBURG, ADJUSTMENT PEDALS ON EITHER SIDE. FOLD FORWARD SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDALS LOCATED ON ALL 4 CORNERS. REMOVABLE 2 HOOK I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

PERSONAL TRANSPORT STRETCHER W/(FIXED HEIGHT) - B286FHC71101 Catalog Number : FHC7110

Device Description : MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. FOLD DOWN SIDE RAILS. BUI MOBILECARE STRETCHER WITH PNEUMATIC BACK ADJUSTMENT. FOLD DOWN SIDE RAILS. BUILT IN O2 CYLINDER STORAGE. CENTRAL LOCKING CASTERS. BRAKE/STEER PEDAL AT EACH CORNER. I.V. POLE AND 4" FOAM MATTRESS INCLUDED. WEIGHT CAPACITY 550LB

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

5TH WHEEL STRETCHER - B286FHC72001 Catalog Number : FHC7200

Device Description : PTF1000 5TH WHEEL TRANSPORT STRETCHER83.32 X 30.569 595.19 LBS

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

5TH WHEEL STRETCHER - B286FHC7200311 Catalog Number : FHC7200-31

Device Description : 5TH WHEEL STRETCHER

Device Class : 2

Duns Number: 188660844

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

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