Polygraf ID 9043G0133

GUDID 07290101363330

A500 Module

Given Imaging, Inc.

Manometric gastrointestinal motility analysis system
Primary Device ID07290101363330
NIH Device Record Key36e0a225-6b01-4a2c-a9c3-6738e3e3573c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolygraf ID
Version Model Number9043G0133
Catalog Number9043G0133
Company DUNS090073722
Company NameGiven Imaging, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry;Fragile;

Device Identifiers

Device Issuing AgencyDevice ID
GS107290101363330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYESYSTEM,ELECTROGASTROGRAPHY(EGG)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-09-24

Devices Manufactured by Given Imaging, Inc.

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04260167480954 - ManoScan2019-11-08 AR 3D Probe
04260167480961 - ManoScan2019-11-08 ESO Catheter, SD Regular
04260167482422 - ManoScan2019-11-08 ESO 3D Catheter
04260167482439 - ManoScan2019-11-08 ESO With Extended Tip
04260167482446 - ManoScan2019-11-08 ESO Z Catheter
04260167482453 - ManoScan2019-11-08 ESO Catheter, SD Small
04260167482460 - ManoScan2019-11-08 AR Catheter, Small

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