FDA.reportPublic FDA data

WARMER, SINGLE CHAMBER

Primary DI
B286SWC243036GMS1
Brand
WARMER, SINGLE CHAMBER
Company
M.A.C. MEDICAL INC.
Model
SWC243036-G-MS
Catalog number
SWC243036-G-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 x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set pointMobile Stand2 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarmKeyed temperature lockDoor lockData loggerFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.35 kw/hr, 1195 btu/hr UL/CUL listedFDA Regist
Published
2016-08-01
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
B286SWC243036GMS1PrimaryHIBCC0

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
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

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