AccessGUDID - DEVICE: ThermoChem (00851450007015)

GUDID

Device Identifier (DI) Information

Brand Name: ThermoChem
Version or Model: IPH Procedure Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 111-2000
Company Name: THERMASOLUTIONS, INC.

Primary DI Number: 00851450007015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 186855925 *Terms of Use

Device Description: The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir.

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?
56634	Intraperitoneal-circulation hypothermia system administration kit	A collection of sterile devices designed to be used in the function of an automated peritoneal lavage system (APLS). It typically includes tubing to connect the infusion/extraction pump mechanism of the control unit and the other components of the system [also known as the lavage administration set (LAS)], a peritoneal lavage catheter, a heat exchanger, a core body temperature probe (e.g., oesophageal), an infusate temperature sensor, a peritoneal pressure sensor, waste receptacle, and other appropriate devices for this treatment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLW	Warmer, Peritoneal Dialysate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Depth: 8 Inch
Width: 15 Inch
Length: 30 Inch
Weight: 11 Pound

Device Record Status

Public Device Record Key: 1ec0d045-0701-49f6-b4ad-67da33987b9d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016