DEVICE: COUNTER TOP/WALL MOUNT SINGLE CHAMBER WARMER, 18 X 15.5 X 22 (B286W1518XSSNB1)

Device Identifier (DI) Information

COUNTER TOP/WALL MOUNT SINGLE CHAMBER WARMER, 18 X 15.5 X 22
W1518XSS-NB
In Commercial Distribution
W1518XSS-NB
M.A.C. MEDICAL INC.
B286W1518XSSNB1
HIBCC

1
188660844 *Terms of Use
Overall size 18”W x 15.5”D x 22”T. 1.4 Cubic ft. storage Chamber I.D. 14”W x 13"D x 13”T Temperature Range: 90-135 F Accuracy +/- 1 degrees F Digital control. Stainless steel door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Door lock Data logger Foot levelers No base Electrical: 120V, 3.5 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr. UL/CUL listed FDA Registered
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
55829 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).
Active false
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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 [?]
K080609 000
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Sterilization

No
No
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

7d778d3d-b1db-48e4-a7de-41adbd64f028
July 06, 2018
3
July 29, 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
No
No
No CLOSE

Customer Contact

[?]
(877) 828-9975
info@macmedical.com
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