AccessGUDID - DEVICE: DUAL CHAMBER BLANKET/FLUID WARMER (B286DWC183074E4B1)

GUDID

Device Identifier (DI) Information

Brand Name: DUAL CHAMBER BLANKET/FLUID WARMER
Version or Model: DWC183074E-4B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWC183074E-4B
Company Name: M.A.C. MEDICAL INC.

Primary DI Number: B286DWC183074E4B1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 188660844 *Terms of Use

Device Description: Overall size 30”W x 20.5”D x 74.5”T. Upper Chamber I.D. 26”W x 17”D x 25”T 6.39 Cubic ft. storage. Lower chamber I.D. 26 “W x 17”D x 26”T 6.65 Cubic ft. storage. Digital control. Foot levelers 3 Adjustable shelves Stainless steel doors Audible and visual over-temp alarm. Keyed temperature lock Data logger Dual upper door lock 4" base Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr. UL/CUL listed.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
LHC	Warmer, Irrigation Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080609	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd7e9eba-b83d-4a56-bf55-566d8f94622f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016