FUTURE HEALTH CONCEPTS, INC.

Address:1211 E. 30th Street,Sanford,FL,32773,US

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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

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size Freestanding 30”W x 20.5”D x 64 - B337FHCSWC60TLGD1 Catalog Number : FHCSWC60-TL-G-D

Device Description : Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 1 Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point3 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarm Data LoggerFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.46 kw/hr, 1570 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET/FLUID WARMER - B337FHCSWC60TLGDMB1 Catalog Number : FHCSWC60-TL-G-D-MB

Device Description : Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 1 Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point3 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarm Mobile base Data LoggerElectrical: 120V, 7.5 Amp, 50/60 Hz.46 kw/hr, 1570 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET/FLUID WARMER - B337FHCSWC60TLGMB1 Catalog Number : FHCSWC60-TL-G-MB

Device Description : Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 1 Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point3 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarm Mobile baseElectrical: 120V, 7.5 Amp, 50/60 Hz.46 kw/hr, 1570 btu/hrUL/CUL listedFDA Registered

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size Freestanding 30”W x 20.5”D x 6 - B337FHCSWC60TLMB1 Catalog Number : FHCSWC60-TL-MB

Device Description : Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 1 Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point3 Adjustable shelvesDigital controlStainless steel doorAudible and visual over-temp alarmMobile baseElectrical: 120V, 7.5 Amp, 50/60 Hz.46 kw/hr, 1570 btu/hr UL/CUL listedFDA Registered

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET / FLUID WARMER - B337FHCSWC7218TL1 Catalog Number : FHCSWC72-18-TL

Device Description : Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic f Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET / FLUID WARMER - B337FHCSWC7218TL2201 Catalog Number : FHCSWC72-18-TL-220

Device Description : Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic f Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers.Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F. Electrical: 220V

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER WARMING CABINET - B337FHCSWC7218TLDM1 Catalog Number : FHCSWC72-18-TL-D-MB

Device Description : Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic f Single chamber blanket/fluid warmer. 30"W X 20.5"D X 74.5"T 18" depth21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Stainless steel door. Audible and visual over-temp alarm. Keyed temperature lock-out. Accuracy +/- 3 degrees F.Data LoggerMobile BaseElectrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET/FLUID WARMER - B337FHCSWC7218TLG1 Catalog Number : FHCSWC72-18-TL-G

Device Description : Single Chamber Blanket/ Fluid Warmer 30"W X 20.5"D X 74.5"T 18" Depth21 Cubic f Single Chamber Blanket/ Fluid Warmer 30"W X 20.5"D X 74.5"T 18" Depth21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers.Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET/FLUID WARMER - B337FHCSWC7218TLG2201 Catalog Number : FHCSWC72-18-TL-G-220

Device Description : Single Chamber Blanket/ Fluid Warmer 30"W X 20.5"D X 74.5"T 18" Depth21 Cubic f Single Chamber Blanket/ Fluid Warmer 30"W X 20.5"D X 74.5"T 18" Depth21 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Electrical: 220V

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size Freestanding 30”W x 20.5”D x - B337FHCSWC7218TLGR1 Catalog Number : FHCSWC72-18-TL-G-R

Device Description : Overall size 30”W x 20.5”D x 74.5”T. Chamber I.D. 26”W x 17”D x 61”T. 15.6 Cub Overall size 30”W x 20.5”D x 74.5”T. Chamber I.D. 26”W x 17”D x 61”T. 15.6 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed Shelves. Foot levelers. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .53kw/hr, 1810 btu/hr. UL/CUL listed.

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

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