AccessGUDID - DEVICE: Start-Up Kit Japan (00849111050081)

GUDID

Device Identifier (DI) Information

Brand Name: Start-Up Kit Japan
Version or Model: CG-500D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-0785-03
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111050081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: 9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

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?
46315	Intravascular core temperature regulation system start kit	A collection of devices intended to be used to facilitate the function of intravascular core temperature regulation system. It typically includes tubing to connect the pump mechanism of the control unit, a heat exchange coil, a spike for insertion into the bag of fluid used in the system (e.g., normal saline), an air trap, a flow indicator, and a Luer-lock connection for the intravascular catheter. 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 [?]
K014241	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: 9 Feet

Device Record Status

Public Device Record Key: a4bf756b-f8e8-41c7-ab7f-066e756858c7
Public Version Date: December 18, 2023
Public Version Number: 4
DI Record Publish Date: October 10, 2016