FDA.reportPublic FDA data

DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T

Primary DI
FHCDWC2424TLLH220
Brand
DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 24”W x 26.5”D x 74.5”T
Company
M.A.C. MEDICAL INC.
Model
FHCDWC2424-TL-LH-220
Catalog number
FHCDWC2424-TL-LH-220
Device description
Overall size 24”W x 26.5”D x 74.5”T. Upper Chamber I.D. 20”W x 23”D x 15.25”T 4.05 Cubic ft. storage. Lower chamber I.D. 20 “W x 23”D x 34.5”T 9.18 Cubic ft. storage. Digital control. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220VKeyed temperature lock. Left HandFoot levelers
Published
2016-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080609000SWC/DWC WARMING CABINETSMac Medical2008-06-13LHC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
FHCDWC2424TLLH220PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
(877) 828-9975info@macmedical.com

Regulatory Flags#

DUNS number
188660844
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B286DWC243074TGRMB1Dual Chamber Warming CabinetDWC243074TGRMB1CMEB-BFW-D-17PT21-G-R-MB2026-10-05
B286SWC243074MBST1Single Chamber Warming CabinetSWC243074-MB-STSWC243074-MB-ST2026-09-30
B286DWC183074TLG4B1Dual Chamber Warming CabinetDWC183074TLG4BDWC183074TLG4B2026-09-18
B286DWC182464TG4B220C1Dual Chamber Warming CabinetDWC182464T-G-4B-220-CDWC182464T-G-4B-220-C2026-08-27
B286DWC243064T4BR21Dual Chamber Warming CabinetDWC243064T-4B-R2DWC243064T-4B-R22026-08-27
B286DWC243074TGLHMB1Dual Chamber Warming CabinetDWC243074T-G-LH-MBDWC243074T-G-LH-MB2026-08-27
B286DWC243074TGMB220C1Dual Chamber Warming CabinetDWC243074T-G-MB-220-CDWC243074T-G-MB-220-C2026-08-27
B286DWC243074TGMBAVT1Dual Chamber Warming CabinetDWC243074T-G-MB-AVTDWC243074T-G-MB-AVT2026-08-27
B286DWC243074TMBAVT1Dual Chamber Warming CabinetDWC243074T-MB-AVTDWC243074T-MB-AVT2026-08-27
B286DWC243074TMBEL220C1Dual Chamber Warming CabinetDWC243074T-MB-EL-220-CDWC243074T-MB-EL-220-C2026-08-27
B286DWC243074TTS4B1Dual Chamber Warming CabinetDWC243074T-TS-4BDWC243074T-TS-4B2026-08-27
B286SWC1518224B1Single Chamber Warming CabinetSWC151822-4BSWC151822-4B2026-08-27
B286SWC151822LHNB1Single CHAMBER WARMING CABINETSWC151822-LH-NBSWC151822-LH-NB2026-08-21
B286SWC242424GNB1Single CHAMBER WARMING CABINETSWC242424-G-NBSWC242424-G-NB2026-08-21
B286DWC183074EG4BC1Dual Chamber Warming CabinetDWC183074E-G-4B-CDWC183074E-G-4B-C2026-08-18
B286DWC183074EGMB220C1Dual Chamber Warming CabinetDWC183074E-G-MB-220-CDWC183074E-G-MB-220-C2026-08-18
B286DWC183074T4BAVT1Dual Chamber Warming CabinetDWC183074T-4B-AVTDWC183074T-4B-AVT2026-08-18
B286DWC183074T4BR21Dual Chamber Warming CabinetDWC183074T-4B-R2DWC183074T-4B-R22026-08-18
B286DWC183074TGMB220C1Dual Chamber Warming CabinetDWC183074T-G-MB-220-CDWC183074T-G-MB-220-C2026-08-18
B286DWC183074TTS4B1Dual Chamber Warming CabinetDWC183074T-TS-4BDWC183074T-TS-4B2026-08-18

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