FDA.reportPublic FDA data

SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size

Primary DI
B337FHCSWC7218TLGR1
Brand
SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size
Company
FUTURE HEALTH CONCEPTS, INC.
Model
FHCSWC72-18-TL-G-R
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 Cubic ft. storage. Digital control. 2 Adjustable shelves. 2 Fixed She
Published
2017-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHCWarmer, Irrigation SolutionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B337FHCSWC7218TLGR1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blanket warming cabinet, dry-heatA mains electricity (AC-powered) device designed to warm blankets with hot dry air. It is typically a high capacity (e.g., 0.2 to 0.5 m3) unit with appropriate perforated shelves for blanket positioning, avoiding contact with very hot surfaces to prevent scorching. Hot dry air is usually circulated to heat blankets in a temperature range from 30 to 90? C (90 to 200? F).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037304144
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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B337BB24X76X31Stretcher Pad Universal 24 X 76 X 3 Regular CoverBB24X76X3BB24X76X32020-09-22
B337BB26X76X41FHC Stretcher Pad 26 X 76 X 4BB26X76X4BB26X76X42020-09-22
B337BB184541FHC Stretcher Pad W/Cut Corners For FHC7100-29, FHC7101 StretcherBB18454BB184542020-09-16
B337BB20801Pad Amsco 1080/2080 2 Thick (Set Of 3)BB2080BB20802020-09-16
B337BB2080D1Pad Amsco Deluxe 2080 2 Thick (Set Of 3)BB2080DBB2080D2020-09-16
B337BB24X75X4WD1FHC Stretcher Pad With Welded Seams 24 X 75 X 4 W/Cut CornersBB24X75X4WDBB24X75X4WD2020-09-16
B337BB24X76X41Stretcher Pad 24 X 76 X 4 Regular CoverBB24X76X4BB24X76X42020-09-16
B337BB25X75X41Stretcher Pad Standard 25 X 75 X 4 Dura-Comfort CoverBB25X75X4BB25X75X42020-09-16
B337BB26X74X31Stretcher Pad 26 X 74 X 3BB26X74X3BB26X74X32020-09-16
B337BB26X75X41Stretcher Pad 26 X 75 X 4BB26X75X4BB26X75X42020-09-16
B337BB26X76X31FHC Stretcher Pad 26 X 76 X 3BB26X76X3BB26X76X32020-09-16
B337BB26X79X41FHC Stretcher Pad 26 X 79 X 4BB26X79X4BB26X79X42020-09-16
B337BB30801Pad Amsco (3080/3085) 2" Thick (Set Of 3)BB3080BB30802020-09-16
B337BB30X76X31Stretcher Pad 30 X 76 X 3 with Dura-Comfort MaterialBB30X76X3BB30X76X32020-09-16
B337BB735X26X31C-Arm Table Deluxe Pad 73.5 x 26 x 3BB73.5X26X3BB73.5X26X32020-09-16
B337BB7625X2875X41Pad Stretcher 28.75 x 73.25 x 4BB76.25X28.75X4BB76.25X28.75X42020-09-16
B337BBCMAX1Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)BBCMAXBBCMAX2020-09-16
B337BBCUSTOMPAD11FHC Custom Table Pad w/Drain Flap 1" Purple Fusion, No VelcroBBCUSTOMPAD-1BBCUSTOMPAD-12020-09-16
B337BBCUSTOMPAD21FHC Custom 4" Stretcher Pad w/Black Comfort CoverBBCUSTOMPAD-2BBCUSTOMPAD-22020-09-16

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