AccessGUDID - DEVICE: Thermal Angel (00861816000307)

GUDID

Device Identifier (DI) Information

Brand Name: Thermal Angel
Version or Model: TA-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Estill Medical Technologies, Inc.

Primary DI Number: 00861816000307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 029148074 *Terms of Use

Device Description: A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSB	Warmer, Blood, Non-Electromagnetic Radiation
LGZ	Warmer, Thermal, Infusion Fluid

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2feed8a3-f879-4caf-a06a-5b6feeafa613
Public Version Date: January 08, 2024
Public Version Number: 1
DI Record Publish Date: December 31, 2023