AccessGUDID - DEVICE: RTX CIRCULATING CASSETTE WITH ELECTROLYTE (00849111075442)

GUDID

Device Identifier (DI) Information

Brand Name: RTX CIRCULATING CASSETTE WITH ELECTROLYTE
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-000830-01
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111075442
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.

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:	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?
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12ea223a-3550-4b93-aa7c-eb631352acb1
Public Version Date: December 18, 2023
Public Version Number: 3
DI Record Publish Date: July 01, 2015