AccessGUDID - DEVICE: Thermogard XP, Lang set B, Rohs, Refurb (00849111075572)

GUDID

Device Identifier (DI) Information

Brand Name: Thermogard XP, Lang set B, Rohs, Refurb
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111075572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.

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:	No
Prescription Use (Rx):	No
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?
44710	Intravascular core temperature regulation system	An assembly of devices intended to regulate a patient's body temperature by circulating a temperature-controlled fluid (e.g., saline solution) through a dedicated, closed-circuit catheter placed in the central venous system (CVS), to both heat and alternatively cool the patient's blood through the transfer of heat as it moves past the catheter. It typically consists of a powered unit that controls fluid temperature and circulation, a catheter with a membrane for heat transfer, temperature probes, and a start kit. It may be used for body temperature regulation during surgery (e.g., cardiac surgery or neurosurgery), intensive care, or for fever management.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NCX	System, Hypothermia, Intravenous, Cooling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072234	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: 19f5bd74-b7f2-46b2-82db-d6642f54e751
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: July 01, 2015