Blanketrol

Basic Information

• Brand Name: Blanketrol
• Primary DI: 10613031871074
• Version / Model: 233
• Catalog Number: 87107
• Company Name: Gentherm Medical, LLC
• Labeler DUNS: 004249462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-25
• Public Version: 1
• Public Version Date: 2024-07-03
• Public Version Status: New
• Public Device Record Key: 019f3c82-257f-4fa5-9a8d-b79d1daabb2e

Device Description

Patient warming and cooling device

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
36956	External circulating-fluid core temperature regulation system control unit, heating/cooling	An electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10613031871074	GS1

Device Sizes

Type	Value	Unit	Text
Weight	59.5	Kilogram
Weight	131	Pound
Height	95.3	Centimeter
Height	37.5	Inch
Depth	43.2	Centimeter
Depth	17.0	Inch
Width	43.2	Centimeter
Width	17.0	Inch