DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T

Basic Information

• Brand Name: DUAL CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T
• Primary DI: B286FHCDWC24TLGSS2201
• Version / Model: FHCDWC24-TL-G-SS-220
• Catalog Number: FHCDWC24-TL-G-SS-220
• Company Name: M.A.C. MEDICAL INC.
• Labeler DUNS: 188660844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-27
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 42c5ec64-7c10-444f-8755-3f81a8fdf4f8

Device Description

Overall size 30”W x 26.5”D x 6 x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 15.25”T 17.2 Cubic ft. storage. Lower chamber I.D. 26 “W x 23”D x 34.5”T 11.93 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Steel and glass doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 220V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHC	Warmer, Irrigation Solution	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B286FHCDWC24TLGSS2201	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080609	000