AccessGUDID - DEVICE: ManoScan (07290101364290)

GUDID

Device Identifier (DI) Information

Brand Name: ManoScan
Version or Model: 4439
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4439
Company Name: Given Imaging, Inc.

Primary DI Number: 07290101364290
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 090073722 *Terms of Use

Device Description: A400 Module

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:	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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gastrointestinal motility analysis system, invasive	An assembly of devices designed to evaluate peristaltic motility anywhere in the gastrointestinal (GI) tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure on an intraluminal catheter/probe placed in the GI tract. It is intended to record, view, and analyse pH, impedance, pressure, and various other input data (e.g., respirations) to assist in the diagnosis and evaluation of GI motility disorders (e.g., dysphagia). The assembly typically includes a monitor display, computer, software, and dedicated measuring probes.

GMDN Preferred Term Name

GMDN Definition

Gastrointestinal motility analysis system, invasive

An assembly of devices designed to evaluate peristaltic motility anywhere in the gastrointestinal (GI) tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure on an intraluminal catheter/probe placed in the GI tract. It is intended to record, view, and analyse pH, impedance, pressure, and various other input data (e.g., respirations) to assist in the diagnosis and evaluation of GI motility disorders (e.g., dysphagia). The assembly typically includes a monitor display, computer, software, and dedicated measuring probes.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091070	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
Special Storage Condition, Specify: Keep dry;Fragile;

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd9788d4-5073-4c78-ba8c-9c1494188c3b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016