AccessGUDID - DEVICE: UniTip High Resolution Catheter (07640172970331)

GUDID

Device Identifier (DI) Information

Brand Name: UniTip High Resolution Catheter
Version or Model: K104059-00-1264-D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Unisensor AG

Primary DI Number: 07640172970331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 483298907 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
62242	Gastrointestinal motility manometric catheter, electronic	A flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen. Also known as a GI solid-state sensor catheter, it is intended for proximal connection to an appropriate gastrointestinal motility analysis system, and the acquired data may be used to generate a 3-D image. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062222	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
Catheter Gauge: 10 French

Device Record Status

Public Device Record Key: 043931b6-b54a-4ad0-8b3f-3ab3088be0fb
Public Version Date: August 05, 2022
Public Version Number: 4
DI Record Publish Date: September 19, 2016