FilteredFlo® Cardiac Blanket

Basic Information

• Brand Name: FilteredFlo® Cardiac Blanket
• Primary DI: 20613031825425
• Version / Model: 542
• Catalog Number: 82542
• Company Name: Gentherm Medical, LLC
• Labeler DUNS: 004249462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-08-30
• Public Version: 3
• Public Version Date: 2021-09-23
• Public Version Status: Update
• Public Device Record Key: 31937451-9203-4609-8f07-072c9208bef8

Device Description

Thermal Regulating System

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47682	Circulating-air whole-body heating/cooling system pad, single-use, sterile	A sterile underlay or overlay through which heated or cooled air is circulated to heat and alternatively cool a patient’s whole body (i.e., elevate or lower core body temperature) typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit. The device is available in a variety of lengths, widths, thicknesses, and shapes to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613031825425	GS1
Unit of Use	10613031825428	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	50.0	Inch
Length	72.0	Inch
Weight	0.7	Pound

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 149 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 60.8 – 75.2 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 16 – 24 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity