AccessGUDID - DEVICE: ThermoGard XP Surface Start-Up Kit (00849111076081)

GUDID

Device Identifier (DI) Information

Brand Name: ThermoGard XP Surface Start-Up Kit
Version or Model: Surface Start-Up Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8700-000936-01
Company Name: Zoll Circulation, Inc.

Primary DI Number: 00849111076081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 799455241 *Terms of Use

Device Description: The Surface Start-Up Kit is a tubing set that connects the Thermogard XP® console to a STx™ Vest or Thermogard™ Vest surface pad. The Surface Start-Up Kit is a closed-loop disposable that is composed of a pre-attached water reservoir, an extension tubing, a pump loop, a heat exchange coil and an air trap assembly. All of these items work with the console to supply cool water to the surface pad to regulate patient core temperature.

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?
67029	External circulating-fluid core temperature regulation system start kit	A collection of consumable devices intended to be used to facilitate the function of an external circulating-fluid core temperature regulation system. It typically includes tubing to connect the pump mechanism of the system control unit to a patient pad, a heat exchange coil, and other necessary components (e.g., water reservoir, air trap, flow indicator). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZE	Hyperthermia Monitor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231182	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: 62b98002-79fc-417b-bbf4-87be20716df3
Public Version Date: May 30, 2024
Public Version Number: 1
DI Record Publish Date: May 22, 2024