AccessGUDID - DEVICE: FilteredFlo® Cardiac Blanket (20613031825425)

GUDID

Device Identifier (DI) Information

Brand Name: FilteredFlo® Cardiac Blanket
Version or Model: 542
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82542
Company Name: Gentherm Medical, LLC

Primary DI Number: 20613031825425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 004249462 *Terms of Use

Device Description: Thermal Regulating System

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Width: 50.0 Inch
Length: 72.0 Inch
Weight: 0.7 Pound

Device Record Status

Public Device Record Key: 31937451-9203-4609-8f07-072c9208bef8
Public Version Date: September 23, 2021
Public Version Number: 3
DI Record Publish Date: August 30, 2017