Bravo FGS-0634

GUDID 07290101369691

Bravo CF reflux recorder

Covidien LP

Gastrointestinal telemetric monitoring system
Primary Device ID07290101369691
NIH Device Record Key80188821-911e-490d-9084-2da02a614040
Commercial Distribution StatusIn Commercial Distribution
Brand NameBravo
Version Model NumberFGS-0634
Catalog NumberFGS-0634
Company DUNS058614483
Company NameCovidien LP
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
Email[email protected]

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS107290101369691 [Primary]

FDA Product Code

NEZSYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
FFTElectrode, pH, stomach

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-26
Device Publish Date2019-08-11

On-Brand Devices [Bravo]

07290101369714Bravoâ„¢ CF capsule delivery dev,1-pk
07290101369707Bravoâ„¢ CF capsule delivery dev, 5-pk
07290101366393pH recorder SW upgrade v136
07290101365303pH Recorder refurbished
07290101364771pH recorder strap, 5-Pack
07290101363064pH recorder
07290101361695pH capsule delivery dev, 5-pk
07290101361688pH capsule delivery dev, 1-pk
07290101369691Bravo CF reflux recorder

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