AccessGUDID - DEVICE: DUAL CHAMBER BLANKET/FLUID WARMER (B286DWC243074EGLH4B1)

GUDID

Device Identifier (DI) Information

Brand Name: DUAL CHAMBER BLANKET/FLUID WARMER
Version or Model: DWC243074E-G-LH-4B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DWC243074E-G-LH-4B
Company Name: M.A.C. MEDICAL INC.

Primary DI Number: B286DWC243074EGLH4B1
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 26.5”D x 74.5”T. 17.59 Cubic ft. storage 4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Glass doors. Left hand hinge Audible and visual over-temp alarm. Keyed temperature lock for each chamber Upper door lock Data logger 4" base Foot levelers Electrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr. UL/CUL listed FDA Registered

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: fa69090b-a7df-4e67-880b-18fed9848600
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016