FDA.reportPublic FDA data

WARMER, SINGLE CHAMBER

Primary DI
SWC2430364B
Brand
WARMER, SINGLE CHAMBER
Company
M.A.C. MEDICAL INC.
Model
SWC243036-4B
Catalog number
SWC243036-4B
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 x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point2 Adjustable shelvesDigital controlStainless steel doorAudible and visual over-temp alarmKeyed temperature lockDoor lockData loggerFoot levelers4"" baseElectrical: 120V, 7.5 Amp, 50/60 Hz.35 kw/hr, 1195 btu/hr UL/CUL listedFDA Regist"
Published
2017-02-13
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
SWC2430364BPrimaryHIBCC0

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).

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
B286IVS10025 Leg I.V. Stand with Manual adjustment lockIVS-1002IVS-10022023-06-08
B286IVS10045 LEG I.V. STAND W/MANUAL ADJUSTMENT LOCKIVS-1004IVS-10042023-06-08
B286IVS20024 LEG I.V. STAND W/MANUAL ADJUSTMENT LOCKIVS-2002IVS-20022023-06-08
B286IVS20044 LEG I.V. STAND W/MANUAL ADJUSTMENT LOCKIVS-2004IVS-20042023-06-08
B286IVS20064 LEG I.V. STAND W/MANUAL ADJUSTMENT LOCKIVS-2006IVS-20062023-06-08
B286IVS302 HOOK IV STAND WITH BRACKETIVS-30-BRKT-CUIVS-30-BRKT-CU2023-06-08
B286IVS30025 LEG I.V. STAND W/FOOT OP. LOCKIVS-3002IVS-30022023-06-08
B286IVS30045 LEG I.V. STAND W/FOOT OP. LOCKIVS-3004IVS-30042023-06-08
B286IVS30065 LEG I.V. STAND W/FOOT OP. LOCK, 6 HOOKIVS-3006IVS-30062023-06-08
B286IVS40024 LEG I.V. STAND W/FOOT OP. LOCKIVS-4002IVS-40022023-06-08
B286IVS40044 LEG I.V. STAND W/FOOT OP. LOCKIVS-4004IVS-40042023-06-08
B286IVS5002BREAK-DOWN 4 LEG IV STAND, 2 HOOKIVS-5002IVS-50022023-06-08
B286IVS5004BREAK-DOWN 4 LEG IV STAND, 4 HOOKIVS-5004IVS-50042023-06-08
B286IVS5006BREAK-DOWN 4 LEG IV STAND, 6 HOOKIVS-5006IVS-50062023-06-08
B286IVS6002BREAK-DOWN 6 LEG IV STAND, 2 HOOKIVS-6002IVS-60022023-06-08
B286IVS6004BREAK-DOWN 6 LEG IV STAND, 4 HOOKIVS-6004IVS-60042023-06-08
B286IVS6006BREAK-DOWN 6 LEG IV STAND, 6 HOOKIVS-6006IVS-60062023-06-08
B286IVS7002BREAK DOWN 5 LEG IV STAND, 2 HOOKIVS-7002IVS-70022023-06-08
B286IVS7004BREAK-DOWN 5 LEG IV STAND, 4 HOOKIVS-7004IVS-70042023-06-08
B286IVS7006BREAK-DOWN 5 LEG IV STAND, 6 HOOKIVS-7006IVS-70062023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426146802Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146925Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146932Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00841027100485Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027100508Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101000Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101109Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101307Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101314Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102793Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102809Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102816Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102823Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027103059Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00748426137855Medline-MicrotekMicrotek Medical LLCLHC2025-11-05
00748426143146Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143153Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143160Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143177Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143184Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143191Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143306Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143313Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143320Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143139Medline-MicrotekMicrotek Medical LLCLHC2025-10-08
00748426140695Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140718Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140725Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140732Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140749Medline-MicrotekMicrotek Medical LLCLHC2025-04-18