DEVICE: SINGLE CHAMBER WARMING CABINET (B286SWC182464LH4B1)

Device Identifier (DI) Information

SINGLE CHAMBER WARMING CABINET
SWC182464-LH-4B
In Commercial Distribution
SWC182464-LH-4B
M.A.C. MEDICAL INC.
B286SWC182464LH4B1
HIBCC

1
188660844 *Terms of Use
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Key temp lock Door lock Data Logger Foot levelers Left hand hinge Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blanket warming cabinet, dry-heat A 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).
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FDA Product Code

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Product Code Product Code Name
LHC Warmer, Irrigation Solution
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

12e9bf45-3699-41c3-9b23-efc3c9f324c3
March 29, 2018
2
August 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No CLOSE

Customer Contact

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(877) 828-9975
info@macmedical.com
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