AccessGUDID - DEVICE: ThermoSuit System (00851936007119)

GUDID

Device Identifier (DI) Information

Brand Name: ThermoSuit System
Version or Model: Training Software
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 76007
Company Name: LIFE RECOVERY SYSTEMS HD LLC

Primary DI Number: 00851936007119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 825390458 *Terms of Use

Device Description: No description.

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":	No
For Single-Use:	No
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?
36172	External circulating-fluid core temperature regulation system control unit, cooling-only	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 lower a patient’s core body temperature. The device includes a refrigeration unit, a pump, and typically a fluid reservoir; it may also be intended for patient temperature monitoring. It is intended to be used by a healthcare professional in a clinical setting typically to treat patients who are hyperthermic/feverish or to induce hypothermia for metabolism reduction (e.g., during surgery).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZE	Hyperthermia Monitor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061023	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 33575718-c827-4dd1-bce6-ba4e8ff6c27c
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: September 08, 2016