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 30”W x 26.5”D x 36”T - B337FHCSWC36TLGMS1 Catalog Number : FHCSWC36-TL-G-MS

Device Description : Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 C Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubic ft. storage. Digital control. 2 Adjustable shelves. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .35kw/hr, 1195 btu/hr. UL/CUL listed.Key temperature lock, Mobile Stand, Foot levelers.

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 30”W x 26.5”D x 36”T - B337FHCSWC36TLMB1 Catalog Number : FHCSWC36-TL-MB

Device Description : Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 C Overall size 30”W x 26.5”D x 6 x 36”T. Chamber I.D. 26”W x 23”D x 25”T. 8.63 Cubic ft. storage. Digital control. 2 Adjustable shelves. Stainless steel door. Audible and visual over-temp alarm. Accuracy +/- 2 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .35kw/hr, 1195 btu/hr. UL/CUL listed.Mobile base

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 30”W x 26.5”D x 36”T - B337FHCSWC36TLMS1 Catalog Number : FHCSWC36-TL-MS

Device Description : Overall size 30”W x 26.5”D x 36”T.8.63 Cubic ft. storageChamber I.D. 26”W x 23”D Overall size 30”W x 26.5”D x 36”T.8.63 Cubic ft. storageChamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point2 Adjustable shelvesDigital controlStainless steel doorAudible and visual over-temp alarmFoot levelers Mobile standElectrical: 120V, 7.5 Amp, 50/60 Hz.35 kw/hr, 1195 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 Overall Size Freestanding 30”W x 20.5”D x 6 - B337FHCSWC60TL1 Catalog Number : FHCSWC60-TL

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 alarmFoot 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 Overall Size Freestanding 30”W x 20.5”D x 6 - B337FHCSWC60TL2201 Catalog Number : FHCSWC60-TL-220

Device Description : Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T.Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Electrical: 220V. 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 Overall Size Freestanding 30”W x 20.5”D x 6 - B337FHCSWC60TLD1 Catalog Number : FHCSWC60-TL-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 controlStainless steel 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 WARMING CABINET SS DOOR MOBILE BASE - B337FHCSWC60TLD220UKMB1 Catalog Number : FHCSWC60-TL-D-220UK-MB

Device Description : Overall size 30”W x 20.5”D x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60 Overall size 30”W x 20.5”D x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T.Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Digital control. Data logger, Foot levelers. 3 Adjustable shelves. Stainless steel door. Audible and visual over-temp alarm. Mobile BaseAccuracy +/- 3 degrees F. Electrical: 220V UL/CUL listed. United Kingdom Plug

Device Class : 1

Duns Number: 037304144

Premarket Exempt : No

Product Code : LHC

Prescription Use : No

Device Count : 1

SINGLE CHAMBER WARMING CABINET SS DOOR, MOBILE BASE - B337FHCSWC60TLDMB1 Catalog Number : FHCSWC60-TL-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 controlStainless steel doorAudible and visual over-temp alarmData LoggerMobile 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 64 - B337FHCSWC60TLG1 Catalog Number : FHCSWC60-TL-G

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 alarmFoot 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 Overall Size Freestanding 30”W x 20.5”D x 64 - B337FHCSWC60TLG2201 Catalog Number : FHCSWC60-TL-G-220

Device Description : Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T.Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Full view glass door. Audible and visual over-temp alarm. Accuracy +/- 3 degrees F. Key temperature lock.Electrical: 220V 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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