AccessGUDID - DEVICE: ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) (00849111075084)

GUDID

Device Identifier (DI) Information

Brand Name: ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin)
Version or Model: IC-3893
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-0657-01
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111075084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
44708	Intravascular core temperature regulation system catheter	A flexible tube with an attached membrane (e.g., a balloon) intended to be inserted into the central venous system (CVS) to circulate through the membrane a temperature-controlled fluid (e.g., saline solution), in order to both heat and alternatively cool a patient's blood through the transfer of heat across the membrane. It may have built-in sensors to monitor the patient's body temperature for feedback to a connected control unit. It may be used for body temperature regulation during surgery, intensive care, or for fever management. This is a single-use device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101987	000

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 38 Centimeter
Catheter Gauge: 9.3 French

Device Record Status

Public Device Record Key: 92bbe5e7-2438-4e19-8b54-d9e2633552ef
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: March 31, 2015