FDA.report

SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size

Primary DI
B337FHCSWC60TL2201
Brand
SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size
Company
FUTURE HEALTH CONCEPTS, INC.
Model
FHCSWC60-TL-220
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 x 60T. Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Dig
Published
2017-01-12
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

Related Records

Product Codes

CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications

CodeDeviceSpecialtyClass
LHCWarmer, Irrigation SolutionPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B337FHCSWC60TL2201PrimaryHIBCC0

GMDN Terms

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

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

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