FilteredFlo® Lower Body OR Blanket

Basic Information

• Brand Name: FilteredFlo® Lower Body OR Blanket
• Primary DI: 20613031834427
• Version / Model: 442
• Catalog Number: 83442
• Company Name: Gentherm Medical, LLC
• Labeler DUNS: 004249462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: ff5db064-2a0c-4978-927b-1a664709121c

Device Description

WarmAir 135 patient warming 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47681	External circulating-air core temperature regulation system pad, single-use	An underlay or overlay through which temperature-regulated air is circulated as part of an external circulating-air core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in surgical and intensive care settings. Air temperature and flow are regulated by a separate control unit (not included). 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20613031834427	GS1
Unit of Use	10613031834420	GS1
Package	30613031834424	GS1	Case	40	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	40.0	Inch
Length	53.0	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 122 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 50 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: 20 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity