FDA.reportPublic FDA data

Distender II Barostat

Primary DI
00627843670940
Brand
Distender II Barostat
Company
G&J Electronics Inc
Model
PPS-9.8
Device description
Protocol Plus Version 9.8 software
Published
2016-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991288000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991288000DISTENDER SERIES II BAROSTATG & J Electronics, Inc.1999-06-08FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627843670940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843670940006278436709406278436709400627843670940

GMDN Terms#

Term, Definition table
TermDefinition
BarostatA computerized pneumatic device designed to measure tension-sensory threshold and motility in the gastrointestinal tract during neurogastroenterology assessment. It maintains a preselected pressure in an intragastric bag (balloon) of a dedicated catheter that is inserted into the gastrointestinal tract (e.g., oesophagus, stomach, intestines, rectum) and registers the pressure changes of the air pumped into the balloon at a predetermined speed (internal pressure data), and simultaneously measures the volume of air that has been used. The collected data can be used in the diagnosis of gastrointestinal disorders such as dysphagia, nausea, vomiting, anorexia, bulimia, or constipation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203222252
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627843670872 Distender II Barostat Main-13002016-11-14
00627843670889Distender II Barostat ERU-13002016-11-14
00627843670896Distender II Barostat ERU-1300-1202016-11-14
00627843670902Distender II Barostat ERU-1202016-11-14
00627843670919Distender II Barostat PP-012016-11-14
00627843670926Distender II Barostat PP-022016-11-14
00627843670933Distender II Barostat KP-012016-11-14
00627843670957Distender II BarostatPPS-10.32019-01-23

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Primary DI, Brand, Company table
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