Thermal Angel Ultra Battery 1

Basic Information

• Brand Name: Thermal Angel Ultra Battery 1
• Primary DI: 00861816000338
• Version / Model: TA-UB1
• Company Name: Estill Medical Technologies, Inc.
• Labeler DUNS: 029148074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-31
• Public Version: 1
• Public Version Date: 2024-01-08
• Public Version Status: New
• Public Device Record Key: aac34fc0-0d70-424f-8d2f-30d98f432ce7

Device Description

The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.

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: 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
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	864.9205	2
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47620	Convection blood/fluid warmer	An electrically-powered device designed for in-line heating of banked blood, blood products, intravenous (IV) solutions, and irrigation fluids, typically from about 4ºC to near body temperature (i.e., 35 to 37ºC) before infusion, through the convection of heat. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); it also includes temperature controls and/or alarms. The warmer is used to minimize adverse thermal reactions in the patient. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00861816000338	GS1
Package	00861816000352	GS1	Case	5	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 80 Degrees Celsius