AccessGUDID - DEVICE: Solar GI HRAM H2O, 24p, Trolley system (08717775955085)

GUDID

Device Identifier (DI) Information

Brand Name: Solar GI HRAM H2O, 24p, Trolley system
Version or Model: G3-14
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Medical Measurement Systems B.V.

Primary DI Number: 08717775955085
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 416277333 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
15036	Gastroduodenal motility analysis system	An assembly of devices designed to evaluate peristaltic motility in the stomach and/or small intestines (usually the duodenum) by measuring pressure on an intragastric catheter/probe at several points. It typically includes a monitor display, computer, software, pressure catheter/probe, and a pH electrode to measure the acidity of the stomach contents. The system is intended to evaluate several diseases of the stomach and small intestines including the prediction of gastric and/or duodenal ulcers.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121014	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: 9676e91a-8854-4078-8235-e647b1b35b9c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016