DEVICE: DUAL CHAMBER BLANKET/FLUID WARMER 30 X 20.5 X 64.75 (B286FHCDWC60TLGD1)

Device Identifier (DI) Information

DUAL CHAMBER BLANKET/FLUID WARMER 30 X 20.5 X 64.75
FHCDWC60-TL-G-D
In Commercial Distribution
FHCDWC60-TL-G-D
M.A.C. MEDICAL INC.
B286FHCDWC60TLGD1
HIBCC

1
188660844 *Terms of Use
Overall size 30”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage 3 Adjustable shelves. Upper Chamber I.D. 26”W x 17”D x 13.5”T 3.46 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 1 degrees F Lower chamber I.D. 26 “W x 17”D x 24.5”T 6.27 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data Logger Foot levelers Electrical: 120V, 10 Amp, 50/60 Hz.
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Device Characteristics

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

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 [?]
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

1fc7880d-c504-4c95-b44c-531c41f250cd
July 06, 2018
3
July 28, 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

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(877) 828-9975
info@macmedical.com
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