AccessGUDID - DEVICE: Lavage Procedure Kit (08719992086016)

GUDID

Device Identifier (DI) Information

Brand Name: Lavage Procedure Kit
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Eight Medical International B.V.

Primary DI Number: 08719992086016
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 490348632 *Terms of Use

Device Description: The disposable single-use Lavage Procedure Kit consists of a Tubing Set, Cannulae, Temperature Probes and a Fluid Reservoir. The Lavage Procedure Kit is supplied sterile.

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:	Yes
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?
40796	Extravascular-circulation hyperthermia system applicator, intracorporeal	A component of a hyperthermia system that typically consists of catheter-enclosed tubing which is introduced into the body either manually or endoscopically. Heated fluid is circulated through the applicator's tubing for localized heating to treat malignant tumours, benign growths, or other disease-related conditions. The applicator (also called an interstitial applicator or probe) typically includes a thermometry component that monitors the temperature of the applicator during operation; it also includes tubing, cables, and connectors that interface with the hyperthermia system's control unit during treatments. It is typically used in an oncology department. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, Thermal, Infusion Fluid

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
No Device Sizes

Device Record Status

Public Device Record Key: 9c46127d-59c2-41bd-b623-81d5034e0834
Public Version Date: December 07, 2022
Public Version Number: 2
DI Record Publish Date: April 10, 2020