AccessGUDID - DEVICE: Quattro, Japan, Final Packaged Kit (Applause) (00849111050050)

GUDID

Device Identifier (DI) Information

Brand Name: Quattro, Japan, Final Packaged Kit (Applause)
Version or Model: IC-4593
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111050050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: No description.

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 15 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 45 Centimeter
Catheter Gauge: 9.3 French

Device Record Status

Public Device Record Key: a060d6c5-3011-4635-9f53-8167388e92e6
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: October 10, 2016